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18F-MFBG Imaging for Neuroendocrine Cancer

Phase 1 & 2

Waitlist Available

Led By Neeta Pandit-Taskar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

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 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new tracer to see how it behaves in the body, how it is removed, and how well it shows neuroendocrine tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on imaging rather than drug treatment, side effects may be minimal but could include discomfort from injection or reactions related to lying still during the PET scan procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

dosimetry of 18F MFBG

radioactivity

Secondary study objectives

18 F-MFBG imaging PET/CT to target known sites of disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: pts with primary or metastatic neuroendocrine tumorsExperimental Treatment3 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.

0 / 1Eligibility criteria met