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18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

NCT02348749 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-19

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Neeta Pandit-Taskar, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2025-03-17
Completion
2025-03-17

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348749 on ClinicalTrials.gov