Bital Savir-Baruch

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Books

• Gabriel, M., & Savir-Baruch, B. (2021). RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0
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  This book, in MCQ format, is a comprehensive tool that will help Nuclear Medicine and Radiology residents and attending physicians to understand concepts in nuclear medicine. Questions cover clinical applications of nuclear medicine techniques to the cardiovascular, pulmonary, endocrine, skeletal, gastrointestinal, genitourinary, and central nervous systems. In addition, topics in physics, radiopharmacy, and radiation safety are addressed. The MCQ format closely resembles that used in board examinations in nuclear medicine. Each question has four possible answers, only one of which is correct. About 60% of the questions are linked to clinical cases, with each case having four questions on average, along with one or two images. The remainder of the questions are free-standing, with or without an image. Answers are concise but are supported by references to the literature when necessary. Pearls in boxes are used to highlight the most important pieces of information. While the questions are scrambled, as in board exams, an index categorizes each question into one of the systems or topics.
• Barron, B., Jablonowski, E., Barron, B. J., & Savir-Baruch, B. (2016). RadTool Nuclear Medicine Flash Facts. doi:10.1007/978-3-319-24636-9
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  This book is a learning aid and reference tool that provides all the important information pertaining to radioactive tracers within a single, easy-to-read volume. It introduces a new learning methodology that will help the reader to recall key facts on each tracer, including production, physical and chemical characteristics, study protocols, mechanism of action, distribution, and clearance. In addition, normal and abnormal tracer distributions are graphically reproduced on an outline of the human body using multiple colors. The book will be of value for all radiologists and medical students seeking a reliable source of essential information on radioactive tracers that can be readily consulted during everyday practice and used in preparation for examinations.

Chapters

• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Cardiovascular System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_4
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  84-year-old male with history of coronary artery disease, s/p stent to mid LAD 3 years ago, atrial fibrillation, s/p biventricular ICD, presented with dyspnea on exertion. He underwent myocardial perfusion pharmacological stress testing with Regadenoson. Images are shown below.
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Central Nervous System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_10
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Endocrine System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_5
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Gastrointestinal System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_8
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  A patient is referred for a hepatobiliary study to rule out biliary dyskinesia given persistent postprandial right upper quadrant pain and nausea. A prior abdominal US was significant for a small polypoid lesion measuring less than 4 mm (Fig. 1a).
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Genitourinary System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_9
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  A 67-year-old female patient is referred for a renogram evaluation due to the CT findings shown in Fig. 1 and subsequent PET/CT findings shown in Fig. 2.
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Miscellaneous. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_12
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Oncology and PET/CT. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_3
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Pulmonary System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_7
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Radionuclide Therapy. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_11
• Gabriel, M., Savir-Baruch, B., Wagner, R., Barron, B., Bova, D., Hassan, A., Rodriguez-Santiago, S., & Kucerova, Y. (2021). Skeletal System. In RadTool Nuclear Medicine MCQs: Board Exam Preparation. doi:10.1007/978-3-030-69281-0_6
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  A 29-year-old female patient is referred for a sacrum MRI (Fig. 1) to further evaluate reports of chronic low back pain, suspicious for sacroiliitis. A 6 × 12 mm oval-shaped lesion within the right ischium which contains a small area of suspected fat signal centrally is described. Subsequently, a CT of the pelvis is performed and demonstrates the lesion to be stable in size and showing mixed density with central lucency probably representing a nidus as could be seen with osteoid osteoma. A bone scan with a SPECT/CT of the pelvis is performed (Fig. 2 and 3).

Journals/Publications

• Andriole, G. L., Scarsbrook, A. F., Savir-Baruch, B., & , L. S. (2023). Impact of F-fluciclovine PET/CT on plans for androgen deprivation therapy in patients with biochemical recurrence of prostate cancer: data analysis from two prospective clinical trials. Urologic oncology, 41(6), 293.e1-293.e7.
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  Despite early detection and primary therapy improvements, biochemical recurrence (BCR) of prostate cancer remains common. The advent of highly sensitive molecular imaging has facilitated identification of men with limited metastatic disease burden that might be more optimally treated with metastases-directed therapy than with androgen deprivation therapy (ADT). The LOCATE (NCT02680041) and FALCON (NCT02578940) trials assessed the impact of F-fluciclovine PET/CT on the management of patients with BCR after curative-intent primary therapy. We performed a secondary analysis of LOCATE and FALCON data to characterize sites of recurrence and management decisions for BCR patients who had an intended management plan including ADT prior to undergoing F-fluciclovine PET/CT.
• Buehner, T. M., Liotta, M., Potkul, R. K., Wagner, R. H., & Savir-Baruch, B. (2023). Initial Experience with the Radiotracer 18F-Fluciclovine PET/CT in Ovarian Cancer. Molecular imaging and biology.
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  Early and accurate staging of ovarian cancer is paramount to disease survival. Conventional imaging including FDG PET/CT are limited in the evaluation of small metastatic lesions. 18F-Fluciclovine has minimal urine and bowel excretion allowing optimal visualization of the abdomen and pelvis. This study examines 18F-fluciclovine uptake in known primary and recurrent ovarian cancer.
• Jani, A. B., Ravizzini, G. C., Gartrell, B. A., Siegel, B. A., Twardowski, P., Saltzstein, D., Fleming, M. T., Chau, A., Davis, P., Chapin, B. F., Schuster, D. M., & , S. S. (2023). Diagnostic Performance and Safety of F-rhPSMA-7.3 Positron Emission Tomography in Men With Suspected Prostate Cancer Recurrence: Results From a Phase 3, Prospective, Multicenter Study (SPOTLIGHT). The Journal of urology, 210(2), 299-311.
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  SPOTLIGHT (NCT04186845) evaluated diagnostic performance and safety of radiohybrid F-rhPSMA-7.3, a novel high-affinity positron emission tomography radiopharmaceutical.
• Surasi, D. S., Eiber, M., Maurer, T., Preston, M. A., Helfand, B. T., Josephson, D., Tewari, A. K., Somford, D. M., Rais-Bahrami, S., Koontz, B. F., Bostrom, P. J., Chau, A., Davis, P., Schuster, D. M., Chapin, B. F., & , L. S. (2023). Diagnostic Performance and Safety of Positron Emission Tomography with F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). European urology, 84(4), 361-370.
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  Radiohybrid (rh) F-rhPSMA-7.3 is a novel high-affinity prostate-specific membrane antigen (PSMA)-targeting radiopharmaceutical for prostate cancer (PCa) imaging.
• Surasi, D., Eiber, M., Maurer, T., Preston, M., Helfand, B., Josephson, D., Tewari, A., Somford, D., Rais-Bahrami, S., Koontz, B., Bostrom, P., Chau, A., Davis, P., Schuster, D., Chapin, B., Allaf, M., Andriole, G., Avery, R., Avril, N., , Barker, H., et al. (2023). Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). European Urology, 84(4). doi:10.1016/j.eururo.2023.06.018
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  Background: Radiohybrid (rh) 18F-rhPSMA-7.3 is a novel high-affinity prostate-specific membrane antigen (PSMA)-targeting radiopharmaceutical for prostate cancer (PCa) imaging. Objective: To evaluate the diagnostic performance and safety of 18F-rhPSMA-7.3 in newly diagnosed PCa patients planned for prostatectomy. Design, setting, and participants: Data on 18F-rhPSMA-7.3 were reported from the phase 3 prospective, multicentre LIGHTHOUSE study (NCT04186819). Outcome measurements and statistical analysis: Patients underwent positron emission tomography/computed tomography (PET/CT) 50–70 min after an injection of 296 MBq 18F-rhPSMA-7.3. Images were interpreted locally and by three blinded independent readers. The coprimary endpoints were patient-level sensitivity and specificity for the detection of pelvic lymph node (PLN) metastases, validated using histopathology at PLN dissection. Prespecified statistical thresholds (lower bounds of 95% confidence interval [CI]) were set at 22.5% for sensitivity and 82.5% for specificity. Results and limitations: Of 372 patients screened, 352 had evaluable 18F-rhPSMA-7.3-PET/CT and 296 (99 [33%] with unfavourable intermediate-risk [UIR] and 197 [67%] with high-/very-high-risk [VHR] PCa) subsequently underwent surgery. As per the independent reads, 23–37 (7.8–13%) patients had 18F-rhPSMA-7.3–positive PLN. Seventy (24%) patients had one or more positive PLNs on histopathology. The sensitivity for PLN detection was 30% (95% CI, 19.6–42.1%) for reader 1, 27% (95% CI, 17.2–39.1%) for reader 2, and 23% (95% CI, 13.7–34.4%) for reader 3, not meeting the prespecified threshold. Specificity was 93% (95% CI, 88.8–95.9%), 94% (95% CI, 89.8–96.6%), and 97% (95% CI, 93.7–98.7%), respectively, exceeding the threshold for all readers. Specificity was high (≥92%) across both risk stratifications. Sensitivity was higher among high-risk/VHR (24–33%) than among UIR (16–21%) patients. Extrapelvic (M1) lesions were reported for 56–98/352 (16–28%) patients who underwent 18F-rhPSMA-7.3-PET/CT irrespective of surgery. Verification of these (predominantly by conventional imaging) gave a verified detection rate of 9.9–14% (positive predictive value, 51–63%). No serious adverse events were observed. Conclusions: Across all risk stratifications, 18F-rhPSMA-7.3-PET/CT had high specificity, meeting the specificity endpoint. The sensitivity endpoint was not met, although higher sensitivity was noted among high-risk/VHR than among UIR patients. Overall, 18F-rhPSMA-7.3-PET/CT was well tolerated, and identified N1 and M1 disease prior to surgery in newly diagnosed PCa patients. Patient summary: In order to select the most appropriate treatment for patients with prostate cancer, it is critical to diagnose the disease burden accurately at initial diagnosis. In this study, we investigated a new diagnostic imaging agent in a large population of men with primary prostate cancer. We found it to have an excellent safety profile and to provide clinically useful information regarding the presence of disease beyond the prostate.
• Taylor, A. T., Fazlur Rahman, A. K., Folks, R. D., Moncayo, V., Savir-Baruch, B., Plaxton, N., Polsani, A., Halkar, R. K., Dubovsky, E. V., Garcia, E. V., & Manatunga, A. (2023). Computer assisted interpretation of Tc-99m mercaptoacetyltriglycine diuretic scintigraphy enhances resident performance. Nuclear medicine communications, 44(6), 427-433.
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  iRENEX is a software module that incorporates scintigraphic and clinical data to interpret 99m Tc- mercaptoacetyltriglycine (MAG3) diuretic studies and provide reasons for their conclusions. Our objectives were to compare iRENEX interpretations with those of expert physicians, use iRENEX to evaluate resident performance and determine if iRENEX could improve the diagnostic accuracy of experienced residents.
• Taylor, A., Fazlur Rahman, A., Folks, R., Moncayo, V., Savir-Baruch, B., Plaxton, N., Polsani, A., Halkar, R., Dubovsky, E., Garcia, E., & Manatunga, A. (2023). Computer assisted interpretation of Tc-99m mercaptoacetyltriglycine diuretic scintigraphy enhances resident performance. Nuclear Medicine Communications, 44(6). doi:10.1097/MNM.0000000000001691
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  Objective iRENEX is a software module that incorporates scintigraphic and clinical data to interpret 99mTc- mercaptoacetyltriglycine (MAG3) diuretic studies and provide reasons for their conclusions. Our objectives were to compare iRENEX interpretations with those of expert physicians, use iRENEX to evaluate resident performance and determine if iRENEX could improve the diagnostic accuracy of experienced residents. Methods Baseline and furosemide 99mTc-MAG3 acquisitions of 50 patients with suspected obstruction (mean age ± SD, 58.7 ± 15.8 years, 60% female) were randomly selected from an archived database and independently interpreted by iRENEX, three expert readers and four nuclear medicine residents with one full year of residency. All raters had access to scintigraphic data and a text file containing clinical information and scored each kidney on a scale from +1.0 to -1.0. Scores ≥0.20 represented obstruction with higher scores indicating greater confidence. Scores +0.19 to -0.19 were indeterminate; scores ≤-0.20 indicated no obstruction. Several months later, residents reinterpreted the studies with access to iRENEX. Receiver operating characteristic (ROC) analysis and concordance correlation coefficient (CCC) quantified agreement. Results The CCC among experts was higher than that among residents, 0.84, versus 0.39, respectively, P < 0.001. When residents reinterpreted the studies with iRENEX, their CCC improved from 0.39 to 0.73, P < 0.001. ROC analysis showed significant improvement in the ability of residents to distinguish between obstructed and non-obstructed kidneys using iRENEX (P = 0.036). Conclusion iRENEX interpretations were comparable to those of experts. iRENEX reduced interobserver variability among experienced residents and led to better agreement between resident and expert interpretations.
• Bulbul, J. E., Grybowski, D., Lovrec, P., Solanki, A. A., Gabriel, M. S., Wagner, R. H., & Savir-Baruch, B. (2022). Positivity Rate of [F]Fluciclovine PET/CT in Patients with Suspected Prostate Cancer Recurrence at PSA Levels Below 1 ng/mL. Molecular imaging and biology, 24(1), 42-49.
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  Early and precise localization of recurrent prostate cancer lesions after local therapy facilitates optimal disease management. Here, we present results from a single-center study to evaluate the utility of [F]fluciclovine PET/CT to localize prostate cancer recurrence in patients with PSA
• Bulbul, J. E., Hashem, A., Grybowski, D., Joyce, C., Rashad, E., Gabriel, M. S., Wagner, R. H., & Savir-Baruch, B. (2022). Effect of hormonal therapy on F-fluciclovine PET/CT in the detection of prostate cancer recurrence, localization of metastatic disease, and correlation with prostate-specific antigen. Urologic oncology, 40(8), 379.e9-379.e16.
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  F-Fluciclovine, is a positron emission tomography (PET) radiotracer approved for the localization of sites of prostate cancer recurrence in men with a rising prostate-specific antigen (PSA) after definitive treatment. To explore the impact of androgen deprivation therapy (ADT) on the performance of F-fluciclovine, we conducted a retrospective analysis to compare the F-fluciclovine PET/CT positivity rate in patients receiving ADT at the time of the scan with the rate achieved in patients not receiving ADT.
• Jadvar, H., Calais, J., Fanti, S., Feng, F., Greene, K. L., Gulley, J. L., Hofman, M., Koontz, B. F., Lin, D. W., Morris, M. J., Rowe, S. P., Royce, T. J., Salami, S., Savir-Baruch, B., Srinivas, S., & Hope, T. A. (2022). Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging. Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 63(1), 59-68.
• Jadvar, H., Calais, J., Fanti, S., Feng, F., Greene, K., Gulley, J., Hofman, M., Koontz, B., Lin, D., Morris, M., Rowe, S., Royce, T., Salami, S., Savir-Baruch, B., Srinivas, S., & Hope, T. (2022). Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging. Journal of Nuclear Medicine, 63(1). doi:10.2967/jnumed.121.263262
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  Prostate cancer is the most common cancer diagnosis in men in the United States and a leading cause of cancer-related morbidity and mortality (1). It can exist along a wide spectrum of aggressiveness and severity, from indolent, very-low-risk, localized prostate cancer to life-threatening, very-high-risk, metastatic prostate cancer. For a newly diagnosed patient in a given clinical state, especially early in the disease, the spectrum of appropriate therapeutic options may range from no intervention to multimodality therapy. Accurate assessment of the extent of disease (e.g., metastatic vs. localized prostate cancer) is essential for guiding treatment decisions. Decision making for the clinical use of imaging and for the development of new imaging technology can both be organized by the framing principles outlined in Prostate Cancer Working group 3 (2). Imaging plays a critical role in that assessment, which has traditionally been done in men at high risk for metastatic disease using a99mTc-methylene diphosphate bone scan and CT (3). Significant advances toward developing more sensitive imaging techniques for detecting the extent of prostate cancer include PET radiopharmaceuticals. Although useful across a wide variety of cancer types,18F-FDG PET has had limited applicability in prostate cancer staging (4). Novel radiopharmaceuticals such as 18F-fluciclovine and choline PET have been used increasingly in the biochemical recurrence (BCR) setting but have limited specificity (5,6). COPYRIGHT
• Love, C., Desai, N. B., Abraham, T., Banks, K. P., Bodei, L., Boike, T., Brown, R. K., Bushnell, D. L., DeBlanche, L. E., Dominello, M. M., Francis, T., Grady, E. C., Hobbs, R. F., Hope, T. A., Kempf, J. S., Pryma, D. A., Rule, W., Savir-Baruch, B., Sethi, I., , Subramaniam, R. M., et al. (2022). ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. American journal of clinical oncology, 45(6), 233-242.
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  This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients.
• Love, C., Desai, N. B., Abraham, T., Banks, K. P., Bodei, L., Boike, T., Brown, R. K., Bushnell, D. L., DeBlanche, L. E., Dominello, M. M., Francis, T., Grady, E. C., Hobbs, R. F., Hope, T. A., Kempf, J. S., Pryma, D. A., Rule, W., Savir-Baruch, B., Sethi, I., , Subramaniam, R. M., et al. (2022). ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. Clinical nuclear medicine, 47(6), 503-511.
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  This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients.
• Love, C., Desai, N., Abraham, T., Banks, K., Bodei, L., Boike, T., Brown, R., Bushnell, D., DeBlanche, L., Dominello, M., Francis, T., Grady, E., Hobbs, R., Hope, T., Kempf, J., Pryma, D., Rule, W., Savir-Baruch, B., Sethi, I., , Subramaniam, R., et al. (2022). ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. American Journal of Clinical Oncology: Cancer Clinical Trials, 45(6). doi:10.1097/COC.0000000000000903
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  Objectives: This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients. Methods: The document was developed according to the systematic process developed by the American College of Radiology (ACR) and described on the ACR Web site (https://www.acr.org/Clinical-Resources/ Practice-Parameters-and-Technical-Standards). The PP development was led by 2 ACR Committees on Practice Parameters (Nuclear Medicine and Molecular Imaging and Radiation Oncology) collaboratively with the American College of Nuclear Medicine, American Society of Radiation Oncology, and Society of Nuclear Medicine and Molecular Imaging. Results: The Lu-177 DOTATATE PP reviewed pharmacology, indications, adverse effects, personnel qualifications, and required clinical evaluation before starting the treatment, as well as the recommended posttherapy monitoring, quality assurance, documentation, and appropriate radiation safety instructions provided in written form and explained to the patients. Conclusions: Lu-177 DOTATATE is available for therapy of inoperable and/or advanced GEP-NETs when conventional therapy had failed. It can reduce tumor size, improve symptoms, and increase the progression free survival. The PP document provides clinical guidance for authorized users to assure an appropriate, consistent, and safe practice of Lu-177 DOTATATE.
• Love, C., Desai, N., Abraham, T., Banks, K., Bodei, L., Boike, T., Brown, R., Bushnell, D., Deblanche, L., Dominello, M., Francis, T., Grady, E., Hobbs, R., Hope, T., Kempf, J., Pryma, D., Rule, W., Savir-Baruch, B., Sethi, I., , Subramaniam, R., et al. (2022). ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. Clinical Nuclear Medicine, 47(6). doi:10.1097/RLU.0000000000004182
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  Objectives This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients. Methods The document was developed according to the systematic process developed by the American College of Radiology (ACR) and described on the ACR Web site (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards). The PP development was led by 2 ACR Committees on Practice Parameters (Nuclear Medicine and Molecular Imaging and Radiation Oncology) collaboratively with the American College of Nuclear Medicine, American Society of Radiation Oncology, and Society of Nuclear Medicine and Molecular Imaging. Results The Lu-177 DOTATATE PP reviewed pharmacology, indications, adverse effects, personnel qualifications, and required clinical evaluation before starting the treatment, as well as the recommended posttherapy monitoring, quality assurance, documentation, and appropriate radiation safety instructions provided in written form and explained to the patients. Conclusions Lu-177 DOTATATE is available for therapy of inoperable and/or advanced GEP-NETs when conventional therapy had failed. It can reduce tumor size, improve symptoms, and increase the progression free survival. The PP document provides clinical guidance for authorized users to assure an appropriate, consistent, and safe practice of Lu-177 DOTATATE.
• Parent, E. E., Savir-Baruch, B., Gayed, I. W., Almaguel, F., Chin, B. B., Pantel, A. R., Armstrong, E., Morley, A., Ippisch, R. C., & Flavell, R. R. (2022). Lu-PSMA Therapy. Journal of nuclear medicine technology, 50(3), 205-212.
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  Radiopharmaceutical therapy using Lu-prostate-specific membrane antigen (PSMA) is an effective prostate cancer treatment that was recently approved by the U.S. Food and Drug Administration. This method leverages the success of PSMA-targeted PET imaging, enabling delivery of targeted radiopharmaceutical therapy; has demonstrated a clear benefit in large prospective clinical trials; and promises to become part of the standard armamentarium of treatment for patients with prostate cancer. This review highlights the evidence supporting the use of this agent, along with important areas under investigation. Practical information on technology aspects, dose administration, nursing, and the role of the treating physician is highlighted. Overall, Lu-PSMA treatment requires close collaboration among referring physicians, nuclear medicine technologists, radiopharmacists, and nurses to streamline patient care.
• Savir-Baruch, B., & Schuster, D. M. (2022). Prostate Cancer Imaging with 18F-Fluciclovine. PET clinics, 17(4), 607-620.
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  18F-Fluciclovine PET is approved for the evaluation of patients with suspected prostate cancer recurrence. 18F-Fluciclovine PET is highly specific for the localization of extraprostatic disease even with negative conventional images and low prostate-specific antigen and has been reported to influence patients' management and improve outcome. With the recent Food and Drug Administration approval of prostate-specific membrane antigen (PSMA) PET, 18F-Fluciclovine is likely to be used as an adjunct modality in patients with suspected occult local recurrence and/or negative PSMA findings.
• Harmon, G., Chan, D., Lee, B., Miller, C., Gorbonos, A., Gupta, G., Quek, M., Woods, M., Savir-Baruch, B., Harkenrider, M. M., & Solanki, A. A. (2021). Validating Modern NRG Oncology Pelvic Nodal and Groupe Francophone de Radiothérapie Urologique Prostate Bed Contouring Guidelines for Post-Prostatectomy Salvage Radiation: A Secondary Analysis of the LOCATE Trial. International journal of radiation oncology, biology, physics, 111(5), 1195-1203.
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  We used the patterns of recurrence on F-fluciclovine positron emission tomography (PET)-computed tomography (CT) in patients enrolled in the LOCATE trial after prostatectomy to evaluate how well the most recent NRG Oncology and Groupe Francophone de Radiothérapie Urologique (GFRU) contouring recommendations encompassed all sites of recurrence in the prostate fossa and pelvic nodes in comparison to former Radiation Therapy Oncology Group (RTOG) recommendations.
• Savir-Baruch, B., Choyke, P. L., Rowe, S. P., Schuster, D. M., Subramaniam, R. M., & Jadvar, H. (2021). Role of F-Fluciclovine and Prostate-Specific Membrane Antigen PET/CT in Guiding Management of Oligometastatic Prostate Cancer: Expert Panel Narrative Review. AJR. American journal of roentgenology, 216(4), 851-859.
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  Twenty-five years ago, oligometastatic disease was proposed as an intermediary clinical state of cancer with unique implications for therapies that may impact cancer evolution and patient outcome. Identification of limited metastases that are potentially amenable to targeted therapies fundamentally depends on the sensitivity of diagnostic tools, including new-generation imaging methods. For men with biochemical recurrence after definitive therapy of the primary prostate cancer, PET/CT using either the FDA-approved radiolabeled amino acid analogue F-fluciclovine or investigational radiolabeled agents targeting prostate-specific membrane antigen (PSMA) enables identification of early metastases at lower serum PSA levels than was previously feasible using conventional imaging. Evidence supports PSMA PET/CT as the most sensitive imaging modality available for identifying disease sites in oligometastatic prostate cancer. PSMA PET/CT will likely become the modality of choice after regulatory approval and will drive the development of trials of emerging metastasis-directed therapies such as stereotactic ablative body radiation and radioguided surgery. Indeed, numerous ongoing or planned clinical trials are studying advances in management of oligometastatic prostate cancer based on this heightened diagnostic capacity. In this rapidly evolving clinical environment, radiologists and nuclear medicine physicians will play major roles in facilitating clinical decision making and management of patients with oligometastatic prostate cancer.
• Savir-Baruch, B., Werner, R. A., Rowe, S. P., & Schuster, D. M. (2021). PET Imaging for Prostate Cancer. Radiologic clinics of North America, 59(5), 801-811.
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  The role of PET imaging with C-choline and F-fluciclovine in evaluating patients with prostate cancer (PCa) has become more important over the years and has been incorporated into the NCCN guidelines. A new generation of PET radiotracers targeting the prostate-specific membrane antigen (PSMA) is widely used outside the United States to evaluate patients with primary PCa and PCa recurrence. PET imaging influences treatment planning and demonstrates a significantly higher disease detection rate than conventional imaging such as computed tomography and MR imaging. Early data indicate that using PET radiotracers such as F-fluciclovine and PSMA improves patient outcomes. 68-Ga-PSMA-11 and 18F-DCFPyL-PET/CT were recently approved by the US Food & Drug Administration (FDA) for clinical use. Other PSMA radiotracers, including fluorinated variants, will likely gain FDA approval in the not-too-distant future.
• Siegel, B. A., Schuster, D. M., & Savir-Baruch, B. (2021). Using F-Fluciclovine PET/CT to Detect Prostate Cancer Recurrence in Patients With Very Low PSA Levels. AJR. American journal of roentgenology, 216(3), W10.
• Farrell, M. B., Galt, J. R., Georgoulias, P., Malhotra, S., Pagnanelli, R., Rischpler, C., & Savir-Baruch, B. (2020). SNMMI Procedure Standard/EANM Guideline for Gated Equilibrium Radionuclide Angiography. Journal of nuclear medicine technology, 48(2), 126-135.
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  The purpose of this document is to assist nuclear medicine practitioners in recommending, performing, interpreting, and reporting the results of gated equilibrium radionuclide angiocardiography (ERNA).
• Lovrec, P., Schuster, D. M., Wagner, R. H., Gabriel, M., & Savir-Baruch, B. (2020). Characterizing and Mitigating Bladder Radioactivity on F-Fluciclovine PET/CT. Journal of nuclear medicine technology, 48(1), 24-29.
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  F-fluciclovine PET is approved for prostate cancer recurrence imaging. According to the radiopharmaceutical package insert, only 3% of the tracer is expected to be excreted in the urine over the first 4 h. Yet, in clinical practice we noticed a higher percentage of bladder excretion. We sought to evaluate and quantify early F-fluciclovine bladder radioactivity and determine whether refraining from voiding before F-fluciclovine injection would mitigate it. In total, 159 patients underwent F-fluciclovine PET/CT imaging as part of their clinical workup. The first 36 patients were instructed to void just before F-fluciclovine injection; the subsequent 123 patients were not asked to void. The SUV and SUV of the bladder, aorta, marrow, liver, and bladder volumes were determined. Comparing SUV of bladder to background, we characterized bladder radioactivity as insignificant (bladder < aorta), mild (bladder > aorta < marrow), moderate (bladder > marrow < liver), or intense (bladder > liver). Differences between the protocols were investigated. Overall, 22% (35/159) of patients had moderate bladder activity and 8.8% (14/159) had intense bladder activity. A negative association was found between bladder volume and SUV A significant difference was found between the voiding and nonvoiding groups, with 38.9% (14/36) versus 17.1% (21/123) of patients, respectively, having moderate bladder activity and 22.2% (8/36) versus 4.9% (6/123) of patients, respectively, having intense bladder activity. Refraining from voiding before F-fluciclovine injection results in significantly lower urinary bladder radioactivity than does purposeful voiding before injection. We have modified our practice accordingly, particularly as moderate and intense bladder activity may mask or mimic local prostate cancer recurrence. Mechanisms underlying this phenomenon should be further investigated.
• Lovrec, P., Schuster, D., Wagner, R., Gabriel, M., & Savir-Baruch, B. (2020). Characterizing and mitigating bladder radioactivity on 18F-fluciclovine PET/CT. Journal of Nuclear Medicine Technology, 48(1). doi:10.2967/jnmt.119.230581
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  18F-fluciclovine PET is approved for prostate cancer recurrence imaging. According to the radiopharmaceutical package insert, only 3% of the tracer is expected to be excreted in the urine over the first 4 h. Yet, in clinical practice we noticed a higher percentage of bladder excretion. We sought to evaluate and quantify early 18F-fluciclovine bladder radioactivity and determine whether refraining from voiding before 18F-fluciclovine injection would mitigate it. Methods: In total, 159 patients underwent 18F-fluciclovine PET/CT imaging as part of their clinical workup. The first 36 patients were instructed to void just before 18F-fluci-clovine injection; the subsequent 123 patients were not asked to void. The SUVmax and SUVmean of the bladder, aorta, marrow, liver, and bladder volumes were determined. Comparing SUVmean of bladder to background, we characterized bladder radioactivity as insignificant (bladder, aorta), mild (bladder. aorta, marrow), moderate (bladder. marrow, liver), or intense (bladder. liver). Differences between the protocols were investigated. Results: Overall, 22% (35/159) of patients had moderate bladder activity and 8.8% (14/159) had intense bladder activity. A negative association was found between bladder volume and SUVmean. A significant difference was found between the voiding and nonvoiding groups, with 38.9% (14/36) versus 17.1% (21/123) of patients, respectively, having moderate bladder activity and 22.2% (8/36) versus 4.9% (6/123) of patients, respectively, having intense bladder activity. Conclusion: Refraining from voiding before 18F-fluciclovine injection results in significantly lower urinary bladder radioactivity than does purposeful voiding before injection. We have modified our practice accordingly, particularly as moderate and intense bladder activity may mask or mimic local prostate cancer recurrence. Mechanisms underlying this phenomenon should be further investigated.
• Nanni, C., Zanoni, L., Bach-Gansmo, T., Minn, H., Willoch, F., Bogsrud, T. V., Edward, E. P., Savir-Baruch, B., Teoh, E., Ingram, F., Fanti, S., & Schuster, D. M. (2020). [F]Fluciclovine PET/CT: joint EANM and SNMMI procedure guideline for prostate cancer imaging-version 1.0. European journal of nuclear medicine and molecular imaging, 47(3), 579-591.
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  The aim of this guideline is to provide standards for the recommendation, performance, interpretation, and reporting of [F]Fluciclovine PET/CT for prostate cancer imaging. These recommendations will help to improve accuracy, precision, and repeatability of [F]Fluciclovine PET/CT for prostate cancer essentially needed for implementation of this modality in science and routine clinical practice.
• Nanni, C., Zanoni, L., Bach-Gansmo, T., Minn, H., Willoch, F., Bogsrud, T., Edward, E., Savir-Baruch, B., Teoh, E., Ingram, F., Fanti, S., & Schuster, D. (2020). [18F]Fluciclovine PET/CT: joint EANM and SNMMI procedure guideline for prostate cancer imaging—version 1.0. European Journal of Nuclear Medicine and Molecular Imaging, 47(3). doi:10.1007/s00259-019-04614-y
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  The aim of this guideline is to provide standards for the recommendation, performance, interpretation, and reporting of [18F]Fluciclovine PET/CT for prostate cancer imaging. These recommendations will help to improve accuracy, precision, and repeatability of [18F]Fluciclovine PET/CT for prostate cancer essentially needed for implementation of this modality in science and routine clinical practice.
• Siegel, B., Schuster, D., & Savir-Baruch, B. (2020). Using 18F-Fluciclovine PET/CT to detect prostate cancer recurrence in patients with very low PSA levels. American Journal of Roentgenology, 216(3). doi:10.2214/AJR.20.24688
• Solanki, A. A., Savir-Baruch, B., Liauw, S. L., Michalski, J., Tward, J. D., Vapiwala, N., Teoh, E. J., & , L. s. (2020). F-Fluciclovine Positron Emission Tomography in Men With Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy and Planning to Undergo Salvage Radiation Therapy: Results from LOCATE. Practical radiation oncology, 10(5), 354-362.
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  Conventional imaging rarely localizes the site(s) of prostate cancer recurrence in patients undergoing evaluation for salvage radiation therapy (sRT) after radical prostatectomy (RP). LOCATE (NCT02680041) was a prospective, multicenter study investigating the impact of F-fluciclovine positron emission tomography and computed tomography (PET/CT) on the management of patients with biochemical recurrence of prostate cancer after curative-intent radiation or RP and negative or equivocal conventional imaging. Our objective was to determine the impact of F-fluciclovine PET/CT on treatment decisions for men planning to undergo sRT for biochemical recurrence post-RP.
• Solanki, A., Savir-Baruch, B., Liauw, S., Michalski, J., Tward, J., Vapiwala, N., Teoh, E., Adler, L., Andriole, G., Belkoff, L., Burzon, D., Chau, A., Dato, P., Duan, F., Farwell, M., Fogelson, S., Gardiner, P., Hanna, L., Hoffman, J., , Intenzo, C., et al. (2020). 18F-Fluciclovine Positron Emission Tomography in Men With Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy and Planning to Undergo Salvage Radiation Therapy: Results from LOCATE. Practical Radiation Oncology, 10(5). doi:10.1016/j.prro.2020.05.007
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  Purpose: Conventional imaging rarely localizes the site(s) of prostate cancer recurrence in patients undergoing evaluation for salvage radiation therapy (sRT) after radical prostatectomy (RP). LOCATE (NCT02680041) was a prospective, multicenter study investigating the impact of 18F-fluciclovine positron emission tomography and computed tomography (PET/CT) on the management of patients with biochemical recurrence of prostate cancer after curative-intent radiation or RP and negative or equivocal conventional imaging. Our objective was to determine the impact of 18F-fluciclovine PET/CT on treatment decisions for men planning to undergo sRT for biochemical recurrence post-RP. Methods and Materials: We conducted a subgroup analysis of post-RP patients enrolled in LOCATE who were planning to undergo sRT with or without hormonal therapy based on prescan documentation. 18F-Fluciclovine PET/CT was performed according to standardized procedures. The treatment plan postscan was compared with the prescan plan, and Fisher exact test was used to determine the impact of prescan prostate-specific antigen (PSA) and Gleason sum (GS) on positivity and anatomic patterns of uptake. Results: A total of 114 patients (median prescan PSA 0.42 [interquartile range, 0.3-1.1] ng/mL) met selection criteria (54% of patients in LOCATE). Forty-eight (42%) had 18F-fluciclovine-avid lesions. Twelve patients (11%) had positive findings only in the prostate bed, 24 (21%) had positivity only in the pelvis (prostate bed or pelvic nodes), and 24 (21%) had extrapelvic findings. PSA >0.5 ng/mL and GS ≥8 were associated with a higher risk of extrapelvic positivity (P < .05). Postscan, 55 (48%) patients had a management change; 37 (32%) had a change in overall treatment approach (ie, omission of sRT); and 18 (16%) had sRT target modification. Conclusions: 18F-Fluciclovine PET/CT is positive in nearly half of patients planning to undergo post-RP sRT with negative/equivocal conventional imaging, with findings frequently leading to changes in management. PSA >0.5 ng/mL and GS ≥8 are associated with a higher risk of extrapelvic positive findings.
• Andriole, G. L., Kostakoglu, L., Chau, A., Duan, F., Mahmood, U., Mankoff, D. A., Schuster, D. M., Siegel, B. A., & , L. S. (2019). The Impact of Positron Emission Tomography with 18F-Fluciclovine on the Treatment of Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial. The Journal of urology, 201(2), 322-331.
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  The prospective, multicenter LOCATE (F Fluciclovine [FACBC] PET/CT in Patients with Rising PSA after Initial Prostate Cancer Treatment) trial assessed the impact of positron emission tomography/computerized tomography with F-fluciclovine on treatment plans in patients with biochemical recurrence of prostate cancer after primary therapy with curative intent.
• Calais, J., Ceci, F., Eiber, M., Hope, T. A., Hofman, M. S., Rischpler, C., Bach-Gansmo, T., Nanni, C., Savir-Baruch, B., Elashoff, D., Grogan, T., Dahlbom, M., Slavik, R., Gartmann, J., Nguyen, K., Lok, V., Jadvar, H., Kishan, A. U., Rettig, M. B., , Reiter, R. E., et al. (2019). F-fluciclovine PET-CT and Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. The Lancet. Oncology, 20(9), 1286-1294.
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  National Comprehensive Cancer Network guidelines consider F-fluciclovine PET-CT for prostate cancer biochemical recurrence localisation after radical prostatectomy, whereas European Association of Urology guidelines recommend prostate-specific membrane antigen (PSMA) PET-CT. To the best of our knowledge, no prospective head-to-head comparison between these tests has been done so far. The aim of this study was to compare prospectively paired F-fluciclovine and PSMA PET-CT scans for localising biochemical recurrence of prostate cancer after radical prostatectomy in patients with low prostate-specific antigen (PSA) concentrations (
• Savir-Baruch, B., Lovrec, P., Solanki, A. A., Adams, W. H., Yonover, P. M., Gupta, G., & Schuster, D. M. (2019). Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR. American journal of roentgenology, 213(4), 851-858.
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  The purpose of this study is to show the performance and evaluate the factors influencing the positivity rate (PR) of commercially produced F-fluciclovine PET/CT in the detection of recurrent prostate cancer in clinical practice. We performed a retrospective cohort study of 152 men who had suspected biochemical recurrence of prostate cancer after receiving initial treatment and underwent fluciclovine PET/CT. PRs were calculated for whole-body, prostate and prostate bed, and extraprostatic locations. The influence of different factors, such as the absolute prostate-specific antigen (PSA) level, PSA kinetics, the Gleason score, and Gleason grade groups, on the PR was evaluated. The overall PR was 81% (123/152) for the whole body, 61% (92/152) for the prostate and prostate bed, and 55% (83/152) for extraprostatic locations. There was a linear increase in the PR with an increasing PSA level ( < 0.001). For the whole body, the PR for PSA levels of less than 1 ng/mL, 1 to less than 2 ng/mL, 2 to less than 5 ng/mL, and 5 or more ng/mL were 58% (32/55), 87% (13/15), 100% (39/39), and 92% (35/38), respectively. No statistically significant linear trend was found between the PR and the PSA level doubling time ( > 0.05). In addition, no statistically significant linear trend was found between the PR and increasing Gleason grade group. However, for every 1-unit increase in a patient's Gleason score, the odds of a positive finding in the extraprostatic location increased by 49% ( < 0.05). Commercially produced fluciclovine PET/CT has a high PR for detection of prostate cancer recurrence and is positively correlated with increasing PSA levels. For extraprostatic disease, the PR increases with higher Gleason scores.
• Tade, F. I., Sajdak, R. A., Gabriel, M., Wagner, R. H., & Savir-Baruch, B. (2019). Best Practices for F-Fluciclovine PET/CT Imaging of Recurrent Prostate Cancer: A Guide for Technologists. Journal of nuclear medicine technology, 47(4), 282-287.
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  F-fluciclovine is a Food and Drug Administration-approved PET tracer indicated for patients suspected to have recurrent prostate cancer based on a prostate-specific antigen rise after prior therapy. F-fluciclovine PET/CT is performed significantly differently from F-FDG PET/CT and requires special attention to patient preparation, injection technique, and imaging time. This article aims to provide nuclear medicine technologists with the best-practice guidelines for the F-fluciclovine PET/CT protocol.
• Gill, H. S., Tade, F., Greenwald, D. T., Yonover, P. M., & Savir-Baruch, B. (2018). Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. Clinical nuclear medicine, 43(1), 23-24.
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  Prostate imaging with F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scan (Axumin) was recently approved by the US Food and Drug Administration for men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels following prior treatment. We present a rare case of a 77-year-old man with suspected recurrent prostate cancer with an incidental finding of advanced-stage breast cancer showing different degrees of F-fluciclovine uptake.
• Savir-Baruch, B., Banks, K. P., McConathy, J. E., Molchanova-Cook, O. P., Parent, E. E., Takalkar, A., Tulchinsky, M., Yu, J. Q., Subramaniam, R. M., & Schuster, D. M. (2018). ACR-ACNM Practice Parameter for the Performance of Fluorine-18 Fluciclovine-PET/CT for Recurrent Prostate Cancer. Clinical nuclear medicine, 43(12), 909-917.
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  The American College of Radiology (ACR) and American College of Nuclear Medicine (ACNM) collaborated to develop a clinical practice document for the performance of fluciclovine positron-emission tomography (PET) / computed tomography (CT) in the evaluation of patients with suspected prostate cancer recurrence based on the elevation of prostate-specific antigen (PSA) level (biochemical recurrence) after prior therapy. Prostate cancer is the third leading cause of cancer death in the United States. Up to 50% of patients diagnosed with prostate cancer will develop biochemical failure after initial therapy. The differentiation of local from extraprostatic recurrence plays a critical role in patient management. The use of functional imaging targeting features of cancer metabolism has proven highly useful in this regard. Amino acid transport is upregulated in prostate cancer. Fluciclovine (anti-1-amino-3-F-18-fluorocyclobutane-1-carboxylic acid, FACBC, Axumin™) is an artificial amino acid PET tracer which demonstrates utility in the diagnosis of recurrent prostate cancer with significant added value to conventional imaging.
• Savir-Baruch, B., Zanoni, L., & Schuster, D. M. (2018). Imaging of Prostate Cancer Using Fluciclovine. The Urologic clinics of North America, 45(3), 489-502.
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  Prostate cancer is the most common cancer and the second leading cause of cancer death in men in the United States. Despite high prevalence, diagnosis and surveillance is limited due to indolent biology. Functional imaging techniques improved the ability to detect disease. Amino acids are building blocks of proteins and intracellular transport is upregulated in prostate cancer. Normal biodistribution patterns of fluciclovine include uptake in the liver and pancreas with minimal to no urine excretion, a distinct advantage for prostate cancer imaging. This review provides a detailed overview of the use of F-18 fluciclovine PET in prostate cancer imaging.
• Savir-Baruch, B., Zanoni, L., & Schuster, D. M. (2017). Imaging of Prostate Cancer Using Fluciclovine. PET clinics, 12(2), 145-157.
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  Prostate cancer is the most common cancer and the second leading cause of cancer death in men in the United States. Despite high disease prevalence, diagnosis and surveillance of the disease with conventional imaging are limited typically because of indolent biology. Functional imaging with advanced molecular techniques improves the ability to detect disease. Amino acids are building blocks of proteins, and intracellular transport of amino acids is upregulated in prostate cancer. This review provides a detailed overview of the use of F-18 fluciclovine PET in prostate cancer imaging.
• Subramaniam, R. M., Frey, K. A., Hunt, C. H., Mercier, G. A., Solnes, L. B., Colletti, P. M., Lu, Y., Savir-Baruch, B., & Williams, H. T. (2017). ACR-ACNM Practice Parameter for the Performance of Dopamine Transporter (DaT) Single Photon Emission Computed Tomography (SPECT) Imaging for Movement Disorders. Clinical nuclear medicine, 42(11), 847-852.
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  This American College of Radiology and American College of Nuclear Medicine joint clinical practice parameter is for performance of dopamine transporter single photon emission computed tomography (SPECT) imaging, for patients with movement disorders. Parkinsonian syndrome (PS) consists of a group of neurodegenerative diseases including Parkinson disease (PD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), and dementia with Lewy bodies (DLB). Accurate diagnosis of PS is critical for clinical management. An important diagnostic dilemma is the differentiation of PS and non-neurodegenerative disorders, such as essential tremor (ET) or drug-induced tremor, due to the overlap of clinical symptoms. The management approach to these conditions is distinctly different. An abnormal iodine-123 ioflupane SPECT scan suggests a decreased amount of dopamine transporter in the striatum, that is, a diagnosis of nigrostriatal neurodegenerative PS, whereas a normal scan suggests ET or other nondegenerative parkinsonism (drug-induced, vascular, or psychogenic).
• Wagner, R. H., Savir-Baruch, B., Gabriel, M. S., Halama, J. R., & Bova, D. (2017). Managing Written Directives: A Software Solution to Streamline Workflow. Journal of nuclear medicine technology, 45(2), 96-101.
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  A written directive is required by the U.S. Nuclear Regulatory Commission for any use of I above 1.11 MBq (30 μCi) and for patients receiving radiopharmaceutical therapy. This requirement has also been adopted and must be enforced by the agreement states. As the introduction of new radiopharmaceuticals increases therapeutic options in nuclear medicine, time spent on regulatory paperwork also increases. The pressure of managing these time-consuming regulatory requirements may heighten the potential for inaccurate or incomplete directive data and subsequent regulatory violations. To improve on the paper-trail method of directive management, we created a software tool using a Health Insurance Portability and Accountability Act (HIPAA)-compliant database. This software allows for secure data-sharing among physicians, technologists, and managers while saving time, reducing errors, and eliminating the possibility of loss and duplication. The software tool was developed using Visual Basic, which is part of the Visual Studio development environment for the Windows platform. Patient data are deposited in an Access database on a local HIPAA-compliant secure server or hard disk. Once a working version had been developed, it was installed at our institution and used to manage directives. Updates and modifications of the software were released regularly until no more significant problems were found with its operation. The software has been used at our institution for over 2 y and has reliably kept track of all directives. All physicians and technologists use the software daily and find it superior to paper directives. They can retrieve active directives at any stage of completion, as well as completed directives. We have developed a software solution for the management of written directives that streamlines and structures the departmental workflow. This solution saves time, centralizes the information for all staff to share, and decreases confusion about the creation, completion, filing, and retrieval of directives.
• Wagner, R. H., Savir-Baruch, B., Halama, J. R., Venu, M., Gabriel, M. S., & Bova, D. (2017). Proof of Concept: Design and Initial Evaluation of a Device to Measure Gastrointestinal Transit Time. Journal of nuclear medicine technology, 45(3), 230-235.
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  Chronic constipation and gastrointestinal motility disorders constitute a large part of a gastroenterology practice and have a significant impact on a patient's quality of life and lifestyle. In most cases, medications are prescribed to alleviate symptoms without there being an objective measurement of response. Commonly used investigations of gastrointestinal transit times are currently limited to radiopaque markers or electronic capsules. Repeated use of these techniques is limited because of the radiation exposure and the significant cost of the devices. We present the proof of concept for a new device to measure gastrointestinal transit time using commonly available and inexpensive materials with only a small amount of radiotracer. We assembled gelatin capsules containing a Ga-citrate-radiolabeled grain of rice embedded in paraffin for use as a point-source transit device. It was tested for stability in vitro and subsequently was given orally to 4 healthy volunteers and 10 patients with constipation or diarrhea. Imaging was performed at regular intervals until the device was excreted. The device remained intact and visible as a point source in all subjects until excretion. When used along with a diary of bowel movement times and dates, the device could determine the total transit time. The device could be visualized either alone or in combination with a barium small-bowel follow-through study or a gastric emptying study. The use of a point-source transit device for the determination of gastrointestinal transit time is a feasible alternative to other methods. The device is inexpensive and easy to assemble, requires only a small amount of radiotracer, and remains inert throughout the gastrointestinal tract, allowing for accurate determination of gastrointestinal transit time. Further investigation of the device is required to establish optimum imaging parameters and reference values. Measurements of gastrointestinal transit time may be useful in managing patients with dysmotility and in selecting the appropriate pharmaceutical treatment.
• Odewole, O. A., Tade, F. I., Nieh, P. T., Savir-Baruch, B., Jani, A. B., Master, V. A., Rossi, P. J., Halkar, R. K., Osunkoya, A. O., Akin-Akintayo, O., Zhang, C., Chen, Z., Goodman, M. M., & Schuster, D. M. (2016). Recurrent prostate cancer detection with anti-3-[(18)F]FACBC PET/CT: comparison with CT. European journal of nuclear medicine and molecular imaging, 43(10), 1773-83.
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  To compare the diagnostic performance of the synthetic amino acid analogue PET radiotracer anti-3-[(18)F]FACBC (fluciclovine) with that of CT in the detection of recurrent prostate carcinoma.
• Odewole, O., Tade, F., Nieh, P., Savir-Baruch, B., Jani, A., Master, V., Rossi, P., Halkar, R., Osunkoya, A., Akin-Akintayo, O., Zhang, C., Chen, Z., Goodman, M., & Schuster, D. (2016). Recurrent prostate cancer detection with anti-3-[18F]FACBC PET/CT: comparison with CT. European Journal of Nuclear Medicine and Molecular Imaging, 43(10). doi:10.1007/s00259-016-3383-8
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  Purpose: To compare the diagnostic performance of the synthetic amino acid analogue PET radiotracer anti-3-[18F]FACBC (fluciclovine) with that of CT in the detection of recurrent prostate carcinoma. Methods: This was a retrospective analysis of 53 bone scan-negative patients with suspected recurrent prostate carcinoma who underwent fluciclovine PET/CT and routine clinical CT within 90 days of each other. The correlation between imaging findings and histology and clinical follow-up was evaluated. Positivity rates and diagnostic performance were calculated for fluciclovine PET/CT and CT. Results: Of 53 fluciclovine PET/CT and 53 CT examinations, 41 (77.4 %) and 10 (18.9 %), respectively, had positive findings for recurrent disease. Positivity rates were higher with fluciclovine PET/CT than with CT at all prostate-specific antigen (PSA) levels, PSA doubling times and original Gleason scores. In the prostate/bed, fluciclovine PET/CT was true-positive in 31 and CT was true-positive in 4 of 51 patients who met the reference standard. In extraprostatic regions, fluciclovine PET/CT was true-positive in 12 and CT was true-positive in 3 of 41 patients who met the reference standard. Of the 43 index lesions used to prove positivity, 42 (97.7 %) had histological proof. In 51 patients with sufficient follow-up to calculate diagnostic performance in the prostate/bed, fluciclovine PET/CT demonstrated a sensitivity of 88.6 %, a specificity of 56.3 %, an accuracy of 78.4 %, a positive predictive value (PPV) of 81.6 %, and a negative predictive value (NPV) of 69.2 %; the respective values for CT were 11.4 %, 87.5 %, 35.3 %, 66.7 % and 31.1 %. In 41 patients with sufficient follow-up to calculate diagnostic performance in extraprostatic regions, fluciclovine PET/CT demonstrated a sensitivity of 46.2 %, a specificity of 100 %, an accuracy of 65.9 %, a PPV of 100 %, and an NPV of 51.7 %; the respective values for CT were 11.5 %, 100 %, 43.9 %, 100 % and 39.5 %. Conclusion: The diagnostic performance of fluciclovine PET/CT in recurrent prostate cancer is superior to that of CT and fluciclovine PET/CT provides better delineation of prostatic from extraprostatic recurrence.
• Tade, F. I., Cohen, M. A., Styblo, T. M., Odewole, O. A., Holbrook, A. I., Newell, M. S., Savir-Baruch, B., Li, X., Goodman, M. M., Nye, J. A., & Schuster, D. M. (2016). Anti-3-18F-FACBC (18F-Fluciclovine) PET/CT of Breast Cancer: An Exploratory Study. Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 57(9), 1357-63.
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  The purpose of this study was to explore the uptake of the synthetic amino acid analog PET radiotracer anti-3-(18)F-FACBC ((18)F-fluciclovine) in breast lesions with correlation to histologic and immunohistochemical characteristics.
• Tade, F., Cohen, M., Styblo, T., Odewole, O., Holbrook, A., Newell, M., Savir-Baruch, B., Li, X., Goodman, M., Nye, J., & Schuster, D. (2016). Anti-3-18F-FACBC (18F-Fluciclovine) PET/CT of breast cancer: An exploratory study. Journal of Nuclear Medicine, 57(9). doi:10.2967/jnumed.115.171389
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  The purpose of this study was to explore the uptake of the synthetic amino acid analog PET radiotracer anti-3-18F-FACBC (18F-fluciclovine) in breast lesions with correlation to histologic and immunohistochemical characteristics. Methods: Twelve women with breast lesions underwent 45-min dynamic PET/CT of the thorax after intravenous administration of 366.3 ± 14.8 (337.44-394.05) MBq of 18F-fluciclovine. Uptake in the primary lesions at 4 representative time points (5, 17, 29, and 41 min) after injection were correlated with histologic, imaging, and clinical findings. The significance of differences in SUVmax and tumor-To-background ratios between malignant and benign tissue were calculated. Correlations of activity to histologic and immunohistochemical cancer subtypes were made including Ki-67 intensity and Nottingham grade (NG). Results: There were 17 breast lesions (4 benign, 13 malignant) including 7 of 13 invasive ductal, 5 of 13 invasive lobular, and 1 of 13 metaplastic carcinomas. There was a significant difference in mean SUVmax ± SD of malignant (6.2 ± 3.2, 6.0 ± 3.2, 5.7 ± 2.8, and 5.6 ± 3.0) versus benign (1.3 ± 0.6, 1.2 ± 0.5, 1.2 ± 0.6, and 1.1 ± 0.5) lesions at 5, 17, 29, and 41 min, respectively (all P # 0.0001). Tumor-Tobackground (aorta, normal breast, and marrow) ratios were also significantly higher in malignant than benign breast lesions (all P # 0.02). The highest 18F-fluciclovine activity seems to be present in triplenegative and NG3 subtypes. Across time points, quantitative Ki-67 had weak positive correlation with SUVmax (R1 5 0.48 [P 5 0.03], R2 5 0.44 [P 5 0.03], R3 5 0.46 [P 5 0.03], R4 5 0.43 [0.06]). In 7 patients, 18F-fluciclovine PET visualized locoregional and distant spread including that of lobular cancer, though identification of hepatic metastases was limited by physiologic background activity. Conclusion: The uptake characteristics of 18F-fluciclovine are reflective of the histologic and immunohistochemical characteristics in suspected breast lesions with greater activity in malignant versus benign etiology. The data from this exploratory study may be useful to design future studies using 18F-fluciclovine PET for breast tumor imaging as well as for detection of locoregional and distant spread.
• Odewole, O. A., Oyenuga, O. A., Tade, F., Savir-Baruch, B., Nieh, P. T., Master, V., Chen, Z., Wang, X., Jani, A. B., Bellamy, L. M., Halkar, R. K., Goodman, M. M., & Schuster, D. M. (2015). Reproducibility and reliability of anti-3-[¹⁸F]FACBC uptake measurements in background structures and malignant lesions on follow-up PET-CT in prostate carcinoma: an exploratory analysis. Molecular imaging and biology, 17(2), 277-83.
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  The aim of this study is to examine the reproducibility of anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F]FACBC) quantitative measurements in key background structures and untreated malignant lesions.
• Odewole, O., Oyenuga, O., Tade, F., Savir-Baruch, B., Nieh, P., Master, V., Chen, Z., Wang, X., Jani, A., Bellamy, L., Halkar, R., Goodman, M., & Schuster, D. (2015). Reproducibility and Reliability of Anti-3-[18F]FACBC Uptake Measurements in Background Structures and Malignant Lesions on Follow-Up PET-CT in Prostate Carcinoma: an Exploratory Analysis. Molecular Imaging and Biology, 17(2). doi:10.1007/s11307-014-0797-1
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  Purpose: The aim of this study is to examine the reproducibility of anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) quantitative measurements in key background structures and untreated malignant lesions.Procedures: Retrospective review of 14 patients who underwent follow-up anti-3-[18F]FACBC positron emission tomography-X-ray computed tomography (PET-CT) for prostate carcinoma recurrence. Standard uptake values (SUV) were measured in both original and follow-up scans in key background structures and untreated malignant lesions. Absolute and percent mean difference in SUV between scans and interclass correlation coefficients (ICC) were also computed.Results: Mean (±SD, range) scan interval was 17.4 months (±7.1, 4–29). %Mean difference in SUVmean was 0.6 except for early-phase blood pool (ICC = 0.4). SUVmax in malignant lesions without interim therapy increased or remained stable over time.Conclusions: Despite variable time interval between scans, FACBC PET-CT demonstrates acceptable reproducibility in key background structures. Untreated malignant lesions showed stable or increased uptake over time. A formal test-retest study is planned.
• Schuster, D. M., Nanni, C., Fanti, S., Oka, S., Okudaira, H., Inoue, Y., Sörensen, J., Owenius, R., Choyke, P., Turkbey, B., Bogsrud, T. V., Bach-Gansmo, T., Halkar, R. K., Nye, J. A., Odewole, O. A., Savir-Baruch, B., & Goodman, M. M. (2014). Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid: physiologic uptake patterns, incidental findings, and variants that may simulate disease. Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 55(12), 1986-92.
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  Anti-1-amino-3-(18)F-fluorocyclobutane-1-carboxylic acid ((18)F-FACBC) is a synthetic amino acid analog PET radiotracer undergoing clinical trials for the evaluation of prostate and other cancers. We aimed to describe common physiologic uptake patterns, incidental findings, and variants in patients who had undergone (18)F-FACBC PET.
• Schuster, D. M., Nieh, P. T., Jani, A. B., Amzat, R., Bowman, F. D., Halkar, R. K., Master, V. A., Nye, J. A., Odewole, O. A., Osunkoya, A. O., Savir-Baruch, B., Alaei-Taleghani, P., & Goodman, M. M. (2014). Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. The Journal of urology, 191(5), 1446-53.
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  We prospectively evaluated the amino acid analogue positron emission tomography radiotracer anti-3-[(18)F]FACBC compared to ProstaScint® ((111)In-capromab pendetide) single photon emission computerized tomography-computerized tomography to detect recurrent prostate carcinoma.
• Schuster, D., Nanni, C., Fanti, S., Oka, S., Okudaira, H., Inoue, Y., Owenius, R., Choyke, P., Turkbey, B., Bogsrud, T., Bach-Gansmo, T., Halkar, R., Nye, J., Odewole, O., Savir-Baruch, B., Goodman, M., & Sörensen, J. (2014). Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid: Physiologic uptake patterns, incidental findings, and variants that may simulate disease. Journal of Nuclear Medicine, 55(12). doi:10.2967/jnumed.114.143628
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  Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid (18F-FACBC) is a synthetic amino acid analog PET radiotracer undergoing clinical trials for the evaluation of prostate and other cancers. We aimed to describe common physiologic uptake patterns, incidental findings, and variants in patients who had undergone 18F- FACBC PET. Methods: Sixteen clinical trials involving 611 18F-FACBC studies from 6 centers, which included dosimetry studies on 12 healthy volunteers, were reviewed. Qualitative observations of common physiologic patterns, incidental uptake, and variants that could simulate disease were recorded and compared with similar observations in studies of the healthy volunteers. Quantitative analysis of select data and review of prior published reports and observations were also made. Results: The liver and pancreas demonstrated the most intense uptake. Moderate salivary and pituitary uptake and variable mild to moderate bowel activity were commonly visualized. Moderate bone marrow and mild muscle activity were present on early images, with marrow activity decreasing andmuscle activity increasing with time. Brain and lungs demonstrated activity less than blood pool. Though 18F-FACBC exhibited little renal excretion or bladder uptake during the clinically useful early imaging time window, mild to moderate activity might accumulate in the bladder and interfere with evaluation of adjacent prostate bed and seminal vesicles in 5%-10% of patients. Uptake might also occur from benign processes such as infection, inflammation, prostatic hyperplasia, and metabolically active benign bone lesions such as osteoid osteoma. Conclusion: Common physiologic uptake patterns were similar to those noted in healthy volunteers. The activity in organs followed the presence of amino acid transport and metabolism described with other amino acid-based PET radiotracers. As with other PET radiotracers such as 18F-FDG, focal nonphysiologic uptake may represent incidental malignancy. Uptake due to benign etiologies distinct from physiologic background also occurred and could lead to misinterpretations if the reader is unaware of them.
• Schuster, D., Nieh, P., Jani, A., Bowman, F., Halkar, R., Master, V., Nye, J., Odewole, O., Osunkoya, A., Goodman, M., Alaei-Taleghani, P., Amzat, R., Bowman, F. D., Goodman, M. M., Halkar, R. K., Jani, A. B., Master, V. A., Nieh, P. T., Nye, J. A., , Odewole, O. A., et al. (2014). Anti-3-[18F]FACBC positron emission tomography-computerized tomography and 111In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: Results of a prospective clinical trial. Journal of Urology, 191(5). doi:10.1016/j.juro.2013.10.065
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  Purpose We prospectively evaluated the amino acid analogue positron emission tomography radiotracer anti-3-[18F]FACBC compared to ProstaScint® (111In-capromab pendetide) single photon emission computerized tomography-computerized tomography to detect recurrent prostate carcinoma. Materials and Methods A total of 93 patients met study inclusion criteria who underwent anti-3-[18F]FACBC positron emission tomography-computerized tomography plus 111In-capromab pendetide single photon emission computerized tomography-computerized tomography for suspected recurrent prostate carcinoma within 90 days. Reference standards were applied by a multidisciplinary board. We calculated diagnostic performance for detecting disease. Results In the 91 of 93 patients with sufficient data for a consensus on the presence or absence of prostate/bed disease anti-3-[ 18F]FACBC had 90.2% sensitivity, 40.0% specificity, 73.6% accuracy, 75.3% positive predictive value and 66.7% negative predictive value compared to 111In-capromab pendetide with 67.2%, 56.7%, 63.7%, 75.9% and 45.9%, respectively. In the 70 of 93 patients with a consensus on the presence or absence of extraprostatic disease anti-3-[18F]FACBC had 55.0% sensitivity, 96.7% specificity, 72.9% accuracy, 95.7% positive predictive value and 61.7% negative predictive value compared to 111In-capromab pendetide with 10.0%, 86.7%, 42.9%, 50.0% and 41.9%, respectively. Of 77 index lesions used to prove positivity histological proof was obtained in 74 (96.1%). Anti-3-[18F]FACBC identified 14 more positive prostate bed recurrences (55 vs 41) and 18 more patients with extraprostatic involvement (22 vs 4). Anti-3-[18F]FACBC positron emission tomography-computerized tomography correctly up-staged 18 of 70 cases (25.7%) in which there was a consensus on the presence or absence of extraprostatic involvement. Conclusions Better diagnostic performance was noted for anti-3-[18F]FACBC positron emission tomography-computerized tomography than for 111In-capromab pendetide single photon emission computerized tomography-computerized tomography for prostate carcinoma recurrence. The former method detected significantly more prostatic and extraprostatic disease. © 2014 by American Urological Association Education and Research, Inc.
• Amzat, R., Taleghani, P., Miller, D. L., Beitler, J. J., Bellamy, L. M., Nye, J. A., Yu, W., Savir-Baruch, B., Osunkoya, A. O., Chen, Z., Auffermann, W. F., Goodman, M. M., & Schuster, D. M. (2013). Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Molecular imaging and biology, 15(5), 633-43.
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  Anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F]FACBC) is a synthetic amino acid positron emission tomography (PET) radiotracer with utility in detection of prostate carcinoma and brain tumors and has also been shown to have uptake in lung tumor cell lines. The purpose of this study is to determine the uptake characteristics of anti-3-[(18)F]FACBC in lung carcinoma and if this radiotracer may help characterize pulmonary lesions.
• Amzat, R., Taleghani, P., Miller, D., Beitler, J., Bellamy, L., Nye, J., Yu, W., Savir-Baruch, B., Osunkoya, A., Chen, Z., Auffermann, W., Goodman, M., & Schuster, D. (2013). Pilot Study of the utility of the synthetic pet amino-acid radiotracer anti-1-amino-3-[18f]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Molecular Imaging and Biology, 15(5). doi:10.1007/s11307-012-0606-7
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  Purpose: Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) is a synthetic amino acid positron emission tomography (PET) radiotracer with utility in detection of prostate carcinoma and brain tumors and has also been shown to have uptake in lung tumor cell lines. The purpose of this study is to determine the uptake characteristics of anti-3-[18F]FACBC in lung carcinoma and if this radiotracer may help characterize pulmonary lesions. Procedures: Ten patients with pulmonary lesions scheduled for surgical resection or biopsy underwent 45-min dynamic PET-CT imaging of the thorax after IV injection of 214.6-384.8MBq of anti-3-[ 18F]FACBC. Anti-3-[18F]FACBC uptake was compared with that of routine 2-deoxy-2-[18F]fluoro-d-glucose ([18F]FDG) PET-CT scans of the same patient and validated with a combination of pathology, imaging and clinical follow-up. Immunohistochemistry for Ki-67 was performed on tissue samples. Results: There were nine malignant (seven lung nodules and two mediastinal nodes), two inflammatory, and one carcinoid lesion ranging from 1 to 3.75 cm. Mean(±SD) SUVmax of malignant lesions was 6.2(±2.6), 5.9(±2.7), 5.9(±3.4), and 5.7(±3.3), at 8, 16, 28, and 40 min, respectively; while for inflammatory lesions at the same time points, 4.1(±0.6), 3.3(±0.9), 2.2(±0.03), and 2.3(±0.03), respectively. The carcinoid tumor had SUVmax of 2.8, 2.6, 1.5, and 0.9 at similar time points. Mean SUVmax of all malignant lesions was higher than that of inflammatory lesions for anti-3-[ 18F]FACBC, and was statistically significant at greater than 28 min post-radiotracer infusion (p < 0.05). There was no significant correlation of anti-3-[18F]FACBC activity with Ki67, though there was a positive trend. There was a strong correlation between anti-3-[18F]FACBC and [18F]FDG uptake. Conclusions: Anti-3-[18F]FACBC uptake in malignant lesions is greater than in inflammatory lesions with a higher degree of separation of uptake on delayed imaging. More comprehensive study is required to determine the diagnostic performance of anti-3-[18F]FACBC in the characterization of pulmonary lesions. © 2013 World Molecular Imaging Society.
• Schuster, D. M., Taleghani, P. A., Nieh, P. T., Master, V. A., Amzat, R., Savir-Baruch, B., Halkar, R. K., Fox, T., Osunkoya, A. O., Moreno, C. S., Nye, J. A., Yu, W., Fei, B., Wang, Z., Chen, Z., & Goodman, M. M. (2013). Characterization of primary prostate carcinoma by anti-1-amino-2-[(18)F] -fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F] FACBC) uptake. American journal of nuclear medicine and molecular imaging, 3(1), 85-96.
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  Anti-1-amino-3-[(18)F] fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F] FACBC) is a synthetic amino acid positron emission tomography (PET) radiotracer with utility in the detection of recurrent prostate carcinoma. The aim of this study is to correlate uptake of anti-3-[(18)F] FACBC with histology of prostatectomy specimens in patients undergoing radical prostatectomy and to determine if uptake correlates to markers of tumor aggressiveness such as Gleason score. Ten patients with prostate carcinoma pre-radical prostatectomy underwent 45 minute dynamic PET-CT of the pelvis after IV injection of 347.8 ± 81.4 MBq anti-3-[(18)F] FACBC. Each prostate was co-registered to a separately acquired MR, divided into 12 sextants, and analyzed visually for abnormal focal uptake at 4, 16, 28, and 40 min post-injection by a single reader blinded to histology. SUVmax per sextant and total sextant activity (TSA) was also calculated. Histology and Gleason scores were similarly recorded by a urologic pathologist blinded to imaging. Imaging and histologic analysis were then compared. In addition, 3 representative sextants from each prostate were chosen based on highest, lowest and median SUVmax for immunohistochemical (IHC) analysis of Ki67, synaptophysin, P504s, chromogranin A, P53, androgen receptor, and prostein. 79 sextants had malignancy and 41 were benign. Highest combined sensitivity and specificity was at 28 min by visual analysis; 81.3% and 50.0% respectively. SUVmax was significantly higher (p
• Folks, R. D., Savir-Baruch, B., Garcia, E. V., Verdes, L., & Taylor, A. T. (2012). Development of a relational database to capture and merge clinical history with the quantitative results of radionuclide renography. Journal of nuclear medicine technology, 40(4), 236-43.
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  Our objective was to design and implement a clinical history database capable of linking to our database of quantitative results from (99m)Tc-mercaptoacetyltriglycine (MAG3) renal scans and export a data summary for physicians or our software decision support system.
• Folks, R., Savir-Baruch, B., Garcia, E., Verdes, L., & Taylor, A. (2012). Development of a relational database to capture and merge clinical history with the quantitative results of radionuclide renography. Journal of Nuclear Medicine Technology, 40(4). doi:10.2967/jnmt.111.101477
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  Our objective was to design and implement a clinical history database capable of linking to our database of quantitative results from 99mTc-mercaptoacetyltriglycine (MAG3) renal scans and export a data summary for physicians or our software decision support system. Methods: For database development, we used a commercial program. Additional software was developed in Interactive Data Language. MAG3 studies were processed using an in-house enhancement of a commercial program. The relational database has 3 parts: a list of all renal scans (the RENAL database), a set of patients with quantitative processing results (the Q2 database), and a subset of patients from Q2 containing clinical data manually transcribed from the hospital information system (the CLINICAL database). To test interobserver variability, a second physician transcriber reviewed 50 randomly selected patients in the hospital information system and tabulated 2 clinical data items: hydronephrosis and presence of a current stent. The CLINICAL database was developed in stages and contains 342 fields comprising demographic information, clinical history, and findings from up to 11 radiologic procedures. A scripted algorithm is used to reliably match records present in both Q2 and CLINICAL. An Interactive Data Language program then combines data from the 2 databases into an XML (extensible markup language) file for use by the decision support system. A text file is constructed and saved for review by physicians. Results: RENAL contains 2,222 records, Q2 contains 456 records, and CLINICAL contains 152 records. The interobserver variability testing found a 95% match between the 2 observers for presence or absence of ureteral stent (k 5 0.52), a 75% match for hydronephrosis based on narrative summaries of hospitalizations and clinical visits (k 5 0.41), and a 92% match for hydronephrosis based on the imaging report (k 5 0.84). Conclusion: We have developed a relational database system to integrate the quantitative results of MAG3 image processing with clinical records obtained from the hospital information system. We also have developed a methodology for formatting clinical history for review by physicians and export to a decision support system. We identified several pitfalls, including the fact that important textual information extracted from the hospital information system by knowledgeable transcribers can show substantial interobserver variation, particularly when record retrieval is based on the narrative clinical records. © 2012 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
• Garcia, E. V., Taylor, A., Folks, R., Manatunga, D., Halkar, R., Savir-Baruch, B., & Dubovsky, E. (2012). iRENEX: a clinically informed decision support system for the interpretation of ⁹⁹mTc-MAG3 scans to detect renal obstruction. European journal of nuclear medicine and molecular imaging, 39(9), 1483-91.
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  Decision support systems for imaging analysis and interpretation are rapidly being developed and will have an increasing impact on the practice of medicine. RENEX is a renal expert system to assist physicians evaluate suspected obstruction in patients undergoing mercaptoacetyltriglycine (MAG3) renography. RENEX uses quantitative parameters extracted from the dynamic renal scan data using QuantEM™II and heuristic rules in the form of a knowledge base gleaned from experts to determine if a kidney is obstructed; however, RENEX does not have access to and could not consider the clinical information available to diagnosticians interpreting these studies. We designed and implemented a methodology to incorporate clinical information into RENEX, implemented motion detection and evaluated this new comprehensive system (iRENEX) in a pilot group of 51 renal patients.
• Garcia, E., Taylor, A., Folks, R., Manatunga, D., Halkar, R., Savir-Baruch, B., & Dubovsky, E. (2012). IRENEX: A clinically informed decision support system for the interpretation of 99mTc-MAG3 scans to detect renal obstruction. European Journal of Nuclear Medicine and Molecular Imaging, 39(9). doi:10.1007/s00259-012-2151-7
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  Purpose: Decision support systems for imaging analysis and interpretation are rapidly being developed and will have an increasing impact on the practice of medicine. RENEX is a renal expert system to assist physicians evaluate suspected obstruction in patients undergoing mercaptoacetyltriglycine (MAG3) renography. RENEX uses quantitative parameters extracted from the dynamic renal scan data using QuantEM™II and heuristic rules in the form of a knowledge base gleaned from experts to determine if a kidney is obstructed; however, RENEX does not have access to and could not consider the clinical information available to diagnosticians interpreting these studies. We designed and implemented a methodology to incorporate clinical information into RENEX, implemented motion detection and evaluated this new comprehensive system (iRENEX) in a pilot group of 51 renal patients. Methods: To reach a conclusion as to whether a kidney is obstructed, 56 new clinical rules were added to the previously reported 60 rules used to interpret quantitative MAG3 parameters. All the clinical rules were implemented after iRENEX reached a conclusion on obstruction based on the quantitative MAG3 parameters, and the evidence of obstruction was then modified by the new clinical rules. iRENEX consisted of a library to translate parameter values to certainty factors, a knowledge base with 116 heuristic interpretation rules, a forward chaining inference engine to determine obstruction and a justification engine. A clinical database was developed containing patient histories and imaging report data obtained from the hospital information system associated with the pertinent MAG3 studies. The system was fine-tuned and tested using a pilot group of 51 patients (21 men, mean age 58.2 ± 17.1 years, 100 kidneys) deemed by an expert panel to have 61 unobstructed and 39 obstructed kidneys. Results: iRENEX, using only quantitative MAG3 data agreed with the expert panel in 87 % (34/39) of obstructed and 90 % (55/61) of unobstructed kidneys. iRENEX, using both quantitative and clinical data agreed with the expert panel in 95 % (37/39) of obstructed and 92 % (56/61) of unobstructed kidneys. The clinical information significantly (p < 0.001) increased iRENEX certainty in detecting obstruction over using the quantitative data alone. Conclusion: Our renal expert system for detecting renal obstruction has been substantially expanded to incorporate the clinical information available to physicians as well as advanced quality control features and was shown to interpret renal studies in a pilot group at a standardized expert level. These encouraging results warrant a prospective study in a large population of patients with and without renal obstruction to establish the diagnostic performance of iRENEX. © 2012 Springer-Verlag.
• Amzat, R., Taleghani, P., Savir-Baruch, B., Nieh, P. T., Master, V. A., Halkar, R. K., Lewis, M. M., Faurot, M., Bellamy, L. M., Goodman, M. M., & Schuster, D. M. (2011). Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clinical nuclear medicine, 36(9), 800-2.
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  Prostate carcinoma is the second most common cause of cancer related mortality in males in the United States. The pattern of metastatic disease of prostate cancer is well recognized, frequently involving sclerotic bone lesions and abdomino-pelvic lymph nodes. -1-amino-3-[F]fluorocyclobutane-1-carboxylic acid (-3-[F] FACBC) is a synthetic amino acid analog positron emission tomography (PET) radiotracer with reported utility in the detection of prostate carcinoma. We present two cases of unusual presentations of prostate carcinoma, one with malignant ascitis and omental implants and the other with lytic bone lesions detected with -3-[F]FACBC.
• Nye, J. A., Jarkas, N., Schuster, D. M., Savir-Baruch, B., Voll, R. J., Camp, V. M., & Goodman, M. M. (2011). Biodistribution and human dosimetry of enantiomer-1 of the synthetic leucine analog anti-1-amino-2-fluorocyclopentyl-1-carboxylic acid. Nuclear medicine and biology, 38(7), 1035-41.
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  The enantiomerically enriched (ee=90%, enantiomer 1) synthetic amino acid (R,S)-anti-1-amino-2-fluorocyclopentyl-1-carboxylic acid (anti-2-[(18)F]FACPC-1) accumulates in malignant cells by elevated transport through the sodium-independent system-L (leucine preferring) amino acid transporter. The purpose of this study was to evaluate in vivo uptake and single-dose toxicity of anti-2-[(18)F]FACPC-1 in animals as well as the individual organ and whole-body dose in humans.
• Nye, J., Jarkas, N., Schuster, D., Savir-Baruch, B., Voll, R., Camp, V., & Goodman, M. (2011). Biodistribution and human dosimetry of enantiomer-1 of the synthetic leucine analog anti-1-amino-2-fluorocyclopentyl-1-carboxylic acid. Nuclear Medicine and Biology, 38(7). doi:10.1016/j.nucmedbio.2011.03.007
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  Introduction: The enantiomerically enriched (ee=90%, enantiomer 1) synthetic amino acid (R,S)-anti-1-amino-2-fluorocyclopentyl-1-carboxylic acid (anti-2-[ 18F]FACPC-1) accumulates in malignant cells by elevated transport through the sodium-independent system-l (leucine preferring) amino acid transporter. The purpose of this study was to evaluate in vivo uptake and single-dose toxicity of anti-2-[ 18F]FACPC-1 in animals as well as the individual organ and whole-body dose in humans. Methods: A DU145 xenograft rodent model was used to measure anti-2-[ 18F]FACPC-1 uptake at 15, 30 and 60 min post-injection. Animals were sacrificed and organs harvested to measure the percent injected activity per organ and to calculate residence time. Anti-2-[ 18F]FACPC-1 toxicity was assessed using a single microdose (37-74 MBq/kg) in nonhuman primates. Their vital signs were monitored for 2 h post-injection for drug-related effects. Human biodistribution studies were collected by sequential whole-body PET/CT scans on six healthy volunteers (three male and three female) for 120 min following a single 247±61 MBq bolus injection of anti-2-[ 18F]FACPC-1. Estimates of radiation dose from anti-2-[ 18F]FACPC-1 to the human body were calculated using recommendations of the MIRD committee and MIRDOSE 3.0 software. Results: High anti-2-[ 18F]FACPC-1 residence time was observed in the pancreas of the rodent model compared to the human data. No abnormal treatment-related observations were made in the nonhuman primate toxicity studies. Human venous blood showed no metabolites of anti-2-[ 18F]FACPC-1 in the first 60 min post-injection. All volunteers showed initially high uptake in the kidneys followed by a rapid washout phase. The estimated effective dose equivalent was 0.0196 mSv/MBq. Conclusion: Anti-2-[ 18F]FACPC-1 showed low background uptake in the brain, thoracic and abdominal cavities of humans, suggesting a possible use for detecting malignant tissues in these regions. © 2011 Elsevier Inc..
• Savir-Baruch, B., Schuster, D. M., Jarkas, N., Master, V. A., Nieh, P. T., Halkar, R. K., Nye, J. A., Lewis, M. M., Crowe, R. J., Voll, R. J., Camp, V. M., Bellamy, L. M., Roberts, D. L., & Goodman, M. M. (2011). Pilot evaluation of anti-1-amino-2-[18F] fluorocyclopentane-1-carboxylic acid (anti-2-[18F] FACPC) PET-CT in recurrent prostate carcinoma. Molecular imaging and biology, 13(6), 1272-7.
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  Anti-1-amino-2-[(18)F]fluorocyclopentane-1-carboxylic acid (anti-2-[(18)F]FACPC) is an unnatural alicyclic amino acid radiotracer with high uptake in the DU-145 prostate cancer cell line in vitro. Our goal was to determine if anti-2-[(18)F]FACPC is useful in the detection of prostate carcinoma.
• Savir-Baruch, B., Schuster, D., Jarkas, N., Master, V., Nieh, P., Halkar, R., Nye, J., Lewis, M., Crowe, R., Voll, R., Camp, V., Bellamy, L., Roberts, D., & Goodman, M. (2011). Pilot evaluation of anti-1-amino-2-[ 18F] fluorocyclopentane-1- carboxylic acid (anti-2-[ 18F] FACPC) PET-CT in recurrent prostate carcinoma. Molecular Imaging and Biology, 13(6). doi:10.1007/s11307-010-0445-3
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  Purpose: Anti-1-amino-2-[ 18F]fluorocyclopentane-1-carboxylic acid (anti-2-[ 18F]FACPC) is an unnatural alicyclic amino acid radiotracer with high uptake in the DU-145 prostate cancer cell line in vitro. Our goal was to determine if anti-2-[ 18F]FACPC is useful in the detection of prostate carcinoma. Procedures: Five patients with elevated PSA (1.1-20.5 ng/mL) after curative therapy for prostate carcinoma underwent 60 min dynamic positron emission tomography (PET) of the pelvis after IV injection of 193-340 MBq of anti-2-[ 18F]FACPC. Uptake was compared against PET scans in the same patients with the leucine analog, anti-1-amino-3-[ 18F]fluorocyclobutane-1-carboxylic acid (anti-[ 18F]FACBC), at similar time points and validated via pathology, clinical, and imaging follow-up. Results: At 5 min, average (±SD) SUVmax of malignant lesions is 4.1(±1.3) for anti-2-[ 18F] FACPC and 4.3(±1.1) for anti-[ 18F]FACBC. Yet, blood pool activity at 5 min is significantly higher for anti-2-[ 18F]FACPC with average (±SD) lesion/blood pool SUVmax/SUVmean ratio of 1.4 (±0.5) vs. 3.0 (±0.9) for anti-[ 18F]FACBC. At 20 min, average (±SD) SUVmax of malignant lesions is 2.6 (±1.0) for anti-2-[ 18F]FACPC and 3.4 (±0.8) for anti-[ 18F]FACBC. Yet, bladder activity at 20 min is significantly more intense for anti-2-[ 18F] FACPC with average (±SD) lesion/bladder SUVmax/SUVmean ratio of 0.3 (±0.8) vs. 2.3 (±1.4) for anti-[ 18F]FACBC. Conclusions: While prostate bed lesions are visible on early imaging with anti-2-[ 18F]FACPC, there is high blood pool activity obscuring nodes. As blood pool fades, nodal uptake decreases and high bladder activity then obscures pelvic structures. Compared with anti-[ 18F]FACBC, imaging characteristics for anti-2-[ 18F]FACPC are unfavorable for pelvic recurrent prostate carcinoma detection. © Academy of Molecular Imaging and Society for Molecular Imaging, 2010.
• Schuster, D. M., Savir-Baruch, B., Nieh, P. T., Master, V. A., Halkar, R. K., Rossi, P. J., Lewis, M. M., Nye, J. A., Yu, W., Bowman, F. D., & Goodman, M. M. (2011). Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology, 259(3), 852-61.
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  To compare the diagnostic performance of the synthetic amino acid analog radiotracer anti-1-amino-3-fluorine 18-fluorocyclobutane-1-carboxylic acid (anti-3-(18)F-FACBC) with that of indium 111 ((111)In)-capromab pendetide in the detection of recurrent prostate carcinoma.
• Schuster, D., Savir-Baruch, B., Nieh, P., Master, V., Halkar, R., Rossi, P., Lewis, M., Nye, J., Yu, W., Bowman, F., & Goodman, M. (2011). Detection of recurrent prostate carcinoma with anti-1-amino-3- 18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology, 259(3). doi:10.1148/radiol.11102023
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  Purpose: To compare the diagnostic performance of the synthetic amino acid analog radiotracer anti -1-amino-3-fluorine18-fluorocyclobutane-1- carboxylic acid(anti-3-18F-FACBC) with that of indium 111(111 In)-capromab pendetide in the detection of recurrent prostate carcinoma. Materials and Methods: This prospective study was approved by the institutional review board and complied with HIPAA guidelines. Written informed consent was obtained. Fifty patients (mean age, 68.3 years ± 8.1 [standard deviation]; age range, 50-90 years) were included in the study on the basis of the following criteria: (a) Recurrence of prostate carcinoma was suspected after definitive therapy for localized disease, (b) bone scans were negative, and (c) anti -3-18F-FACBC positron emission tomography (PET)/computed tomography (CT) and 111In - capromab pendetide single photon emission computed tomography (SPECT)/CT were performed within 6 weeks of each other. Studies were evaluated by two experienced interpreters for abnormal uptake suspicious for recurrent disease in the prostate bed and extraprostatic locations. The reference standard was a combination of tissue correlation, imaging, laboratory, and clinical data. Diagnostic performance measures were calculated and tests of the statistical significance of differences determined by using the McNemar χ2 test as well as approximate tests based on the difference between two proportions. Results: For disease detection in the prostate bed, anti-3-18F-FACBC had a sensitivity of 89 % (32 of 36 patients; 95% confidence interval [CI]: 74%, 97%), specificity of 67% (eight of 12 patients; 95% CI: 35%, 90%), and accuracy of 83% (40 of 48 patients; 95% CI: 70%, 93%). 111In-capromab pendetide had a sensitivity of 69% (25 of 36 patients; 95% CI: 52%, 84%), specificity of 58% (seven of 12 patients; 95% CI: 28%, 85%), and accuracy of 67% (32 of 48 patients; 95% CI: 52%, 80%). In the detection of extraprostatic recurrence, anti-3-18F-FACBC had a sensitivity of 100% (10 of 10 patients; 95% CI: 69%, 100%), specificity of 100% (seven of seven patients; 95% CI: 59%, 100%), and accuracy of 100% (17 of 17 patients; 95% CI: 80%, 100%). 111In - capromab pendetide had a sensitivity of 10% (one of 10 patients; 95% CI: 0%, 45%), specificity of 100% (seven of seven patients; 95% CI: 59%, 100%), and accuracy of 47% (eight of 17 patients; 95% CI: 23%, 72%). Conclusion: anti-3-18F-FACBC PET/CT was more sensitive than 111In-capromab pendetide SPECT/CT in the detection of recurrent prostate carcinoma and is highly accurate in the differentiation of prostatic from extraprostatic disease. © RSNA, 2011.

Proceedings Publications

• Savir-Baruch, B., Lovrec, P., Solanki, A., Adams, W., Yonover, P., Gupta, G., & Schuster, D. (2019). Fluorine-18-labeled fluciclovine PET/CT in clinical practice: Factors affecting the rate of detection of recurrent prostate cancer. In SNMMI.
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  OBJECTIVE. The purpose of this study is to show the performance and evaluate the factors influencing the positivity rate (PR) of commercially produced 18F-fluciclovine PET/CT in the detection of recurrent prostate cancer in clinical practice. MATERIALS AND METHODS. We performed a retrospective cohort study of 152 men who had suspected biochemical recurrence of prostate cancer after receiving initial treatment and underwent fluciclovine PET/CT. PRs were calculated for whole-body, prostate and prostate bed, and extraprostatic locations. The influence of different factors, such as the absolute prostate-specific antigen (PSA) level, PSA kinetics, the Gleason score, and Gleason grade groups, on the PR was evaluated. RESULTS. The overall PR was 81% (123/152) for the whole body, 61% (92/152) for the prostate and prostate bed, and 55% (83/152) for extraprostatic locations. There was a linear increase in the PR with an increasing PSA level (p < 0.001). For the whole body, the PR for PSA levels of less than 1 ng/mL, 1 to less than 2 ng/mL, 2 to less than 5 ng/mL, and 5 or more ng/mL were 58% (32/55), 87% (13/15), 100% (39/39), and 92% (35/38), respectively. No statistically significant linear trend was found between the PR and the PSA level doubling time (p > 0.05). In addition, no statistically significant linear trend was found between the PR and increasing Gleason grade group. However, for every 1-unit increase in a patient’s Gleason score, the odds of a positive finding in the extraprostatic location increased by 49% (p < 0.05). CONCLUSION. Commercially produced fluciclovine PET/CT has a high PR for detection of prostate cancer recurrence and is positively correlated with increasing PSA levels. For extraprostatic disease, the PR increases with higher Gleason scores.