18F-MFBG: Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
Study 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
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. 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.
3. 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 Criteria:
1. The subject was previously entered into this study.
2. The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study.
3. The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
4. The subject is unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan.
5. 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.
Primary outcome measure(s)
PET Scan Identification of Neuroblastoma — Imaging at 60 minutes Focal 18F-mFBG uptake (presence or absence) when imaging at 60 minutes with PET/CT or PET/MR, reported as positive and negative predictive agreement with expert oncologist assessment for presence of neuroblastoma
Trial sites (8)
Facility
City
Region
Status
Children's Hospital Los Angeles
Los Angeles
California
University of California, San Francisco
San Francisco
California
Riley Hospital for Children - Indiana University
Indianapolis
Indiana
Dana-Farber Cancer Institute
Boston
Massachusetts
University of Michigan Health System
Ann Arbor
Michigan
Memorial Sloan Kettering Cancer Center
New York
New York
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
The Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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