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

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)43 enrolled

Overview

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

This is a prospective, Phase 3, multi-center, open-label study designed to assess the use of 18F-mFBG PET imaging in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results. Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG or 18F-FDG scan within 30 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies. 18F-mFBG PET studies and clinical 123I-mIBG scans will be evaluated off-site by 3 independent radiologists and/or nuclear medicine physicians who are blinded to all subject information. Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with presence of neuroblastoma (Disease +) or absence of disease (Disease -). Subject-level diagnostic performance will be assessed on the basis of positive and negative percent agreement (PPA and NPA) between the blinded 18F-mFBG scan interpretations and disease status (+ or - for neuroblastoma) as independently assessed by an Expert Panel of pediatric oncologists. Secondary efficacy analyses will compare PPA and NPA between 18F-mFBG and 123I-mIBG interpretations provided by the blinded readers.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Neuroblastoma

Interventions

18F-MFBGDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (8)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: Imaging at 60 minutes

Secondary Outcomes

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

This objective will be assessed using the secondary endpoint of focal increased 123I-mIBG uptake (presence or absence), reported as positive and negative predictive agreement with expert oncologist assessment for presence of neuroblastoma

Time frame: 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.

Description: Assessments based on changes between pre- and post-18F-mFBG administration physical examination findings, vital signs measurements, blood test results including hematology and biochemistry, and electrocardiograms (ECGs).

Time frame: 24 hours following 18F-mFBG administration.

Data from ClinicalTrials.gov

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