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

NCT07833631 | Completed FDA Drug

• 1 other identifier: IRP101-305
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroblastoma

Keywords

Diagnosis of Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Determine Sensitivity, Specificity, Positive and Negative Predictive Percent Agreement (PPA/NPA) of 18F-mFBG

  The primary objective of this study is to demonstrate that 18F-mFBG PET scintigraphy (PET/CT or PET/MR) is sensitive and specific (in terms of positive and negative percent agreement (PPA and NPA) on a subject-level in confirming or excluding the presence of neuroblastoma.

  Blinded Reader review over 2-3 weeks.

Secondary Outcomes (1)

• PPA/NPA on a region/organ system level

  Blinded reader evaluation over 2-3 weeks.

Study Arms (1)

18F-mFBG Revaluation Group

Subjects previously administered 18F-mFBG with: a) a current diagnosis of neuroblastoma; b) a diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma.

Drug: 18F-MFBG

Interventions

18F-MFBG DRUG

Quantity of 18F-mFBG administered to each subject was determined based on the protocol specifications of the original trial at each participating site. No 18F-mFBG will be administered in this study.

18F-mFBG Revaluation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The planned population will consist of subjects with previously established presence or absence of active neuroblastoma. Individuals enrolled as healthy controls in 18F-mFBG trials may be included.

You may qualify if:

• 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.

You may not qualify if:

• \- 1. There is insufficient correlative imaging and clinical follow-up data to establish subject disease status as of the date of 18F-mFBG imaging.
• \. 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.

Sponsors & Collaborators

• Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC): lead

Study Sites (1)

Innervate Radiopharmaceuticals LLC

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

3-fluorobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Arnold F Jacobson, MD PhD

  Innervate Radiopharmaceuticals LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 22, 2026
• Study Start: June 1, 2026
• Primary Completion: July 30, 2026
• Study Completion: August 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

US (1)