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The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all the organs and how it is removed from the body. We will also study how long 18F-MFBG lasts in the blood after administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a PET-CT or PET MR scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pts with primary or metastatic neuroendocrine tumors | Experimental | 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. Patients who show lesion detection by MFBG may be eligible for repeat imaging scan with 18 F- MFBG, at the discretion of PI or study investigator(s). All parameters and technical details of scanning will be as per the study and first imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-MFBG (meta-fluoro benzylguanidine) | Radiation | About 8mCi of 18F-MFBG will be administered to adult patients. Pediatric dose will be based upon adjustment using BSA to the dose of 8 mCi for 1.7m2 BSA ± 10% with maximum activity of 8 mCi. The tracer will be given intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| dosimetry of 18F MFBG | 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. | 1 year |
| radioactivity | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 18 F-MFBG imaging PET/CT to target known sites of disease | 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. |
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Inclusion Criteria:
Phase I:
Expansion Cohort:
Patients with diagnosis of NB (in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement)
Patients must be able to undergo PET scan without sedation
Patients must have prior MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.
Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on Lansky scale for patients ≤16 years of age.
Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.
Patients with positive lesion detection by 18F-MFBG may be eligible for repeat imaging scan, at the discretion of PI or study investigator(s).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeta Pandit-Taskar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 23, 2025 | |
| Reset | Jan 14, 2026 | |
| Release | Feb 6, 2026 | |
| Reset | Feb 24, 2026 | |
| Release | Mar 20, 2026 | |
| Reset | Apr 8, 2026 | |
| Release | May 1, 2026 | |
| Reset | May 27, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 23, 2025 | Jan 14, 2026 | |||
| Feb 6, 2026 |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C107924 | 3-fluorobenzylguanidine |
| D049268 | Positron-Emission Tomography |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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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
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|
| Positron emission tomography (PET) imaging | Device | 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. |
|
| Blood draws | Other | 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) |
|
| 1 year |
| Feb 24, 2026 |
| Mar 20, 2026 | Apr 8, 2026 |
| May 1, 2026 | May 27, 2026 |
| Jun 19, 2026 |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |