New York, New York 10065


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.


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. 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.


Study is Available At:


Original ID:

14-138


NCT ID:

NCT02348749


Secondary ID:


Study Acronym:


Brief Title:

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies


Official Title:

A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies


Overall Status:

Recruiting


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

5 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Neeta Pandit-Taskar, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Primary Contact:Neeta Pandit-Taskar, MD
212-639-3046
Backup Contact:Shakeel Modak, MD
212-639-7623

Study Dates

Start Date:January 2015
Completion Date:January 2021
Completion Type:Anticipated
Primary Completion Date:January 2021
Primary Completion Type:Anticipated
Verification Date:November 2019
Last Changed Date:November 13, 2019
First Received Date:January 19, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:18 F-MFBG imaging PET/CT to target known sites of disease
Time Frame:1 year
Safety Issues:False
Description:Lesion detection will be evaluated based on per patient and per lesion basis. The segmental distribution method described for 123 I -MIBG imaging (modified curie scoring system will be used- appendix C). If, for each individual patient, there is a concord
Outcome Type:Primary Outcome
Measure:radioactivity
Time Frame:1 year
Safety Issues:False
Description:Multiple samples will be counted and time activity curve generated for evaluation of serum clearance. Blood samples will be centrifuged and the plasma pipetted, weighed and counted to determine the plasma time activity concentration curves (% injected dos
Outcome Type:Primary Outcome
Measure:dosimetry of 18F MFBG
Time Frame:1 year
Safety Issues:False
Description:in two cohorts of patients: (a) those with NB and (b) those with non-NB NE. Data will be derived from blood draws and PET/CT scans at multiple time points after injection of 18F-MFBG IV.

Study Interventions

Intervention Type:Radiation
Name:18F-MFBG (meta-fluoro benzylguanidine)
Description:Adult patients: about 8-12 mCi of 18F-MFBG will be administered intravenously. Pediatric patients: 12 mCi/1.7m2 IV (up to a maximum of 12mCi).
Arm Name:pts with primary or metastatic neuroendocrine tumo
Intervention Type:Device
Name:Positron emission tomography (PET) imaging
Description: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.
Arm Name:pts with primary or metastatic neuroendocrine tumo
Intervention Type:Other
Name:Blood draws
Description: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)
Arm Name:pts with primary or metastatic neuroendocrine tumo

Study Arms

Study Arm Type:Experimental
Arm Name:pts with primary or metastatic neuroendocrine tumors
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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