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

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.

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.

• 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.