Status:
COMPLETED
Open-Label Study of 18F-mFBG for Imaging Neuroblastoma
Lead Sponsor:
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Collaborating Sponsors:
New Approaches to Neuroblastoma Therapy Consortium
Memorial Sloan Kettering Cancer Center
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This is a Phase 3 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for confirming or excluding the presence of neuroblastoma
Detailed Description
This is a prospective, Phase 3, multi-center, open-label study designed to assess the use of 18F-mFBG PET imaging in subjects with known or presumed neuroblastoma. Eligible participants will have eith...
Eligibility Criteria
Inclusion
- a) An established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrolment in the trial; OR b) A presumed diagnosis of neuroblastoma based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results, including individuals in whom therapy has already been empirically initiated.
- The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including at least one functional imaging study (123I-mIBG or 18F-FDG), within 30 days prior to the date of 18F-mFBG imaging, with no interval therapy between such evaluation and investigational drug administration.
- Ability of subject or subject's legal guardian to understand and sign a written informed consent document, including, for subjects age 7-17, an assent form.
Exclusion
- The subject was previously entered into this study.
- The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study.
- The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
- The subject is unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan.
- The subject uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04724369
Start Date
November 18 2021
End Date
May 1 2024
Last Update
March 26 2025
Active Locations (8)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Riley Hospital for Children - Indiana University
Indianapolis, Indiana, United States, 46202
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215