Back to results18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
Primary Purpose
Neuroendocrine Tumors
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-MFBG (meta-fluoro benzylguanidine)
Positron emission tomography (PET) imaging
Blood draws
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring 18F-MFBG Imaging, 14-138, PET/MR, PET/CT scan
Eligibility 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.
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pts with primary or metastatic neuroendocrine tumors
Arm 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 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.
Outcomes
Primary Outcome Measures
dosimetry of 18F MFBG
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.
radioactivity
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.
Secondary Outcome Measures
18 F-MFBG imaging PET/CT to target known sites of disease
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.
Full Information
NCT ID
NCT02348749
First Posted
January 19, 2015
Last Updated
March 31, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02348749
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
18F-MFBG Imaging, 14-138, PET/MR, PET/CT scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model 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 or PET/CT scanner
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pts with primary or metastatic neuroendocrine tumors
Arm Type
Experimental
Arm 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 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.
Intervention Type
Radiation
Intervention Name(s)
18F-MFBG (meta-fluoro benzylguanidine)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Positron emission tomography (PET) imaging
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Blood draws
Intervention 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)
Primary Outcome Measure Information:
Title
dosimetry of 18F MFBG
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.
Time Frame
1 year
Title
radioactivity
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 dose/liter), as well as for metabolite analysis of the 18F-MFBG compound by HPLC and/or TCA methodology.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
18 F-MFBG imaging PET/CT to target known sites of disease
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 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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeta Pandit-Taskar, MD
Phone
212-639-3046
First Name & Middle Initial & Last Name or Official Title & Degree
Shakeel Modak, MD
Phone
212-639-7623
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Phone
212-639-3046
First Name & Middle Initial & Last Name & Degree
Shakeel Modak, MD
Phone
212-639-7623
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
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