- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02348749
18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
April 16, 2024 updated by: Memorial Sloan Kettering Cancer Center
A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Neeta Pandit-Taskar, MD
- Phone Number: 212-639-3046
Study Contact Backup
- Name: Shakeel Modak, MD
- Phone Number: 212-639-7623
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dosimetry of 18F MFBG
Time Frame: 1 year
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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.
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1 year
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radioactivity
Time Frame: 1 year
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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 dose/liter), as well as for metabolite analysis of the 18F-MFBG compound by HPLC and/or TCA methodology.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18 F-MFBG imaging PET/CT to target known sites of disease
Time Frame: 1 year
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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 concordance of ≥70% of segments or lesion detection between MIBG and 18 F-MFBG , the latter will be considered as effectively targeting lesions.
For discordant lesions, if MFBG imaging shows 2 or more lesions that are positive on other concurrent or follow up conventional imaging, it will be considered optimal targeting.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
January 19, 2015
First Submitted That Met QC Criteria
January 22, 2015
First Posted (Estimated)
January 28, 2015
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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