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18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

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ClinicalTrials.gov Identifier: NCT02348749
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Radiation: 18F-MFBG (meta-fluoro benzylguanidine) Device: Positron emission tomography (PET) imaging Other: Blood draws Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.
Radiation: 18F-MFBG (meta-fluoro benzylguanidine)
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).

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)




Primary Outcome Measures :
  1. dosimetry of 18F MFBG [ Time Frame: 1 year ]
    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.

  2. radioactivity [ Time Frame: 1 year ]
    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 :
  1. 18 F-MFBG imaging PET/CT to target known sites of disease [ Time Frame: 1 year ]
    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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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348749


Contacts
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Contact: Neeta Pandit-Taskar, MD 212-639-3046
Contact: Shakeel Modak, MD 212-639-7623

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neeta Pandit-Taskar, MD    212-639-3046      
Contact: Shakeel Modak, MD    212-639-7623      
Principal Investigator: Neeta Pandit-Taskar         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02348749     History of Changes
Other Study ID Numbers: 14-138
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
18F-MFBG Imaging
14-138
PET/MR
PET/CT scan
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue