18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

NCT ID: NCT02348749

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2025-03-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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. 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.

Group Type: EXPERIMENTAL

18F-MFBG (meta-fluoro benzylguanidine)

Intervention Type: 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.

Positron emission tomography (PET) imaging

Intervention Type: 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

Intervention Type: 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)

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DEVICE

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Phase I:

• Eligible patients include patients with histologically proven Neuroendocrine tumors (paraganglioma, PHEO, or well differentiated NET of the lung or GI system) or NB. Patients who have NB, the diagnosis must be in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement. Patients must be ≥5 years of age and able to undergo PET scan without sedation
• All patients must have 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.

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.

• If MIBG scan is available within 4 weeks of MFBG, with no intervening treatment, MIBG scan will not be repeated.
• If prior MIBG scan is available >4 weeks of MFBG, MIBG scan will be done within a week (prior or after) of MFBG.
• 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

• Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic toxicity more than grade 2.
• Active serious infections not controlled by antibiotics.
• Inability or unwillingness to undergo PET scanning
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Women who are pregnant or breastfeeding.
• Patient has an active malignancy of metastatic potential other than the known NE tumor for the past 3 years.
• Patients should not have received chemotherapy or radiation therapy (localized radiation therapy is allowed to non-evaluable sites) between prior 123I-MIBG scan and 18F-MFBG administration.
• Patients requiring anesthesia, who are not already undergoing anesthesia for standard-of-care procedures.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeta Pandit-Taskar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-138

Identifier Type: -

Identifier Source: org_study_id