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

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

Overview

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.

This is a study involving blinded interpretation of existing 18F-mFBG PET images. No subjects will be administered 18F-mFBG. Previously collected 18F-mFBG PET studies will be evaluated by 5 independent radiologists and/or nuclear medicine physicians. They will have access to limited clinical information on the reason subject was undergoing evaluations at the time of 18F-mFBG imaging but be blinded to all other subject information. Blinded readers will record the findings on 18F-mFBG scans judged consistent with presence of neuroblastoma and the disease status (+ or -) of the subjects. Subject-level performance of 18F-mFBG PET will be assessed on the basis of positive and negative percent agreement with presence of at least 1 lesion identified by a blinded reader confirmed as neuroblastoma on clinical standard-of-care imaging and histopathology evaluations. Region/organ system level diagnostic performance will be assessed on the basis of positive and negative percent agreement between the blinded 18F-mFBG scan interpretations and disease status in the corresponding region on clinical standard-of-care imaging and histopathology evaluations. Both assessments will utilize the clinical information gathered as part of the trials or locally-authorized clinical use in which the 18F-mFBG scans were acquired and relevant clinical follow-up available at the imaging sites.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuroblastoma

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Blinded Reader review over 2-3 weeks.

Secondary Outcomes

PPA/NPA on a region/organ system level

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 region/organ system level in confirming or excluding the presence of neuroblastoma.

Time frame: Blinded reader evaluation over 2-3 weeks.