NCT02348749

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
RADIATION	18F-MFBG (meta-fluoro benzylguanidine)	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.
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)

Timeline

• Start date: 2015-01-01
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2015-01-28
• Last updated: 2025-03-19

Locations

1 site across 1 country: United States