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

NCT04724369 | Completed Phase 3 FDA Drug

• 1 other identifier: IRP101-301
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 8

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

Conditions

Neuroblastoma

Keywords

18F-mFBG; meta-fluorobenzylguanidine

Outcome Measures

Primary Outcomes (1)

• PET Scan Identification of Neuroblastoma

  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

  Imaging at 60 minutes

Secondary Outcomes (2)

• Comparison of 18F-mFBG PET With Clinical 123I-mIBG Imaging

  Scan interpretation up to one month after intervention.

• Number of subjects with adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.

  24 hours following 18F-mFBG administration.

Study Arms (1)

Study Cohort: Subjects with known or presumed neuroblastoma

EXPERIMENTAL

Drug: 18F-mFBG Positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for identification of neuroblastoma. Other Names: * meta-fluorobenzylguanidine * IRP101

Drug: 18F-MFBG

Interventions

18F-MFBG DRUG

Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent

Also known as: meta-fluorobenzylguanidine, IRP101

Study Cohort: Subjects with known or presumed neuroblastoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC): lead
• New Approaches to Neuroblastoma Therapy Consortium: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (8)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, 46202, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison of PET imaging interpretation and expert assessment for presence or absence of neuroblastoma tumor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 26, 2021
• Study Start: November 18, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)