18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02348749
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Neeta Pandit-Taskar, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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.

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Neeta Pandit-Taskar, MD

212-639-3046

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