18F-MFBG Imaging for Neuroendocrine Cancer

Overseen By Shakeel Modak, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Major organ toxicity, Active infections, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for patients with certain neuroendocrine tumors, such as paraganglioma and neuroblastoma, who are over 5 years old and can have a PET scan without sedation. They must show signs of the tumor on a specific type of scan (MIBG) and not have severe organ damage or other serious illnesses.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I

A single dose of 18F-MFBG is injected intravenously, followed by pharmacokinetics and bio distribution evaluation using non-invasive PET scanning and blood assays at multiple time points post-injection.

1-2 weeks

Multiple visits for PET scanning and blood assays

Expansion Phase

A single dose of 18F-MFBG is injected intravenously, followed by a single time point imaging using PET MR scanner or PET/CT. Additional imaging for patients showing lesion detection.

1-2 weeks

1 visit for PET MR or PET/CT scan, optional repeat imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lesion detection evaluation and dosimetry analysis.

1 year

Treatment Details

Interventions

• 18F-MFBG
• Positron Emission Tomography (PET) Imaging

Trial Overview Researchers are testing a new imaging agent called 18F-MFBG to see how it distributes in the body, its elimination process, and if it's effective at showing neuroendocrine tumors on PET scans. Participants will undergo PET imaging and blood tests.

Participant Groups

Group I: pts with primary or metastatic neuroendocrine tumors Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+