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Completed NCT07833631

A Prospective Image Reevaluation Study to Assess the Efficacy of 18F-mFBG PET Imaging in Subjects With Neuroblastoma

Conditions: Neuroblastoma

Sex: All
Healthy volunteers: Yes
Enrollment: 43
Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Location: Innervate Radiopharmaceuticals LLC Englewood New Jersey

Summary

This is a prospective image revaluation study designed to assess the performance of 18F-mFBG PET imaging in detecting the presence of neuroblastoma. Eligible participants will have undergone 18F-mFBG PET imaging in a research trial or locally-authorized clinical use and have: a) an established diagnosis of active neuroblastoma; or b) an established diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma based on signs, symptoms, imaging findings, and laboratory results.

Eligibility Criteria

Inclusion Criteria: * a) The subject has undergone 18F-mFBG imaging in a previous research trial (including as a non-disease control) or locally-authorized clinical use. Disease status (+ or - for neuroblastoma) as of the date of 18F-mFBG imaging was established based on data collected as part of the previous clinical trial or locally-authorized clinical use or during subsequent clinical follow-up. Exclusion Criteria: \- 1. There is insufficient correlative imaging and clinical follow-up data to establish subject disease status as of the date of 18F-mFBG imaging. 2\. 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07833631). StuddyBuddy aggregates publicly available trial information.