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Clinical Trials in the USA / NCT04724369
Completed Phase 3

Open-Label Study of 18F-mFBG for Imaging Neuroblastoma

NCT04724369 · tracked via the Priya Life Science USA tracker
Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Phase
Phase 3
Started
2021-11-18
Last updated
2026-09-17

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

18F-MFBG

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)

Trial sites (8)

FacilityCityRegionStatus
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.

View NCT04724369 on ClinicalTrials.gov ↗ ← All trials in the USA