18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
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|ClinicalTrials.gov Identifier: NCT02348749|
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Radiation: 18F-MFBG (meta-fluoro benzylguanidine) Device: Positron emission tomography (PET) imaging Other: Blood draws||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||For phase I, a single dose of 18F-MFBG will be injected intravenously in patients. For all patients, pharmacokinetics and bio distribution will be evaluated using non invasive PET scanning and blood assays at multiple time points post injection. In the expansion phase, a single dose of 18F-MFBG will be injected intravenously followed by a single time point imaging using PET MR or PET/CT scanner|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: pts with primary or metastatic neuroendocrine tumors
For phase I, a single dose of 18F-MFBG will be injected intravenously in patients. For all patients, pharmacokinetics and bio distribution will be evaluated using non invasive PET scanning and blood assays at multiple time points post injection. In the expansion phase, a single dose of 18F-MFBG will be injected intravenously followed by a single time point imaging using PET MR scanner or PET/CT. In expansion cohort, an additional 50 patients with NB will be imaged. Patients will receive a single dose of 18F-MFBG intravenously, followed by a whole body PET scan on PET/CT or PET/CT scanner at 60-90 minutes post injection.
Radiation: 18F-MFBG (meta-fluoro benzylguanidine)
Adult patients: about 8-12 mCi of 18F-MFBG will be administered intravenously. Pediatric patients: 12 mCi/1.7m2 IV (up to a maximum of 12mCi).
Device: Positron emission tomography (PET) imaging
Dynamic imaging for the first 30 min over the chest and Whole body (WB) PET-CT scan. Imaging 2 (~1.0 - 2 hours post dose): Whole body (vertex to feet) PET-CT scan. Imaging 3 (~3-4 hours post dose): Whole body (vertex to feet) PET-CT scan.
Other: Blood draws
Blood samples to be collected: at baseline, 5, 15, 30, 60, 90, 120 and 180 mins post injection on the day of administration. (Phase I only)
- dosimetry of 18F MFBG [ Time Frame: 1 year ]in two cohorts of patients: (a) those with NB and (b) those with non-NB NE. Data will be derived from blood draws and PET/CT scans at multiple time points after injection of 18F-MFBG IV.
- radioactivity [ Time Frame: 1 year ]Multiple samples will be counted and time activity curve generated for evaluation of serum clearance. Blood samples will be centrifuged and the plasma pipetted, weighed and counted to determine the plasma time activity concentration curves (% injected dose/liter), as well as for metabolite analysis of the 18F-MFBG compound by HPLC and/or TCA methodology.
- 18 F-MFBG imaging PET/CT to target known sites of disease [ Time Frame: 1 year ]Lesion detection will be evaluated based on per patient and per lesion basis. The segmental distribution method described for 123 I -MIBG imaging (modified curie scoring system will be used- appendix C). If, for each individual patient, there is a concordance of ≥70% of segments or lesion detection between MIBG and 18 F-MFBG , the latter will be considered as effectively targeting lesions. For discordant lesions, if MFBG imaging shows 2 or more lesions that are positive on other concurrent or follow up conventional imaging, it will be considered optimal targeting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348749
|Contact: Neeta Pandit-Taskar, MD||212-639-3046|
|Contact: Shakeel Modak, MD||212-639-7623|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Neeta Pandit-Taskar, MD 212-639-3046|
|Contact: Shakeel Modak, MD 212-639-7623|
|Principal Investigator: Neeta Pandit-Taskar|
|Principal Investigator:||Neeta Pandit-Taskar, MD||Memorial Sloan Kettering Cancer Center|