Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma

PRIMARY OBJECTIVE: I. To estimate the concordance in International Neuroblastoma Response Criteria (INRC) response designations at the end of induction as assessed by iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) central reads in patients with high-risk stage L2 and stage M neuroblastoma. SECONDARY OBJECTIVES: I. To describe individual metastatic lesion response using 123I-MIBG and 18F-MFBG imaging at diagnosis and end-induction. II. To describe concordance in central Curie score between 123I-MIBG and 18F-MFBG imaging. III. To describe concordance in end of induction response designations (poor end-of induction response versus \[vs.\] good end-of induction response) as assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy. IV. To describe concordance as assessed by 123I-MIBG and 18F-MFBG in the INRC components of primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites in patients receiving high-risk therapy. EXPLORATORY OBJECTIVES: I. To describe concordance in International Neuroblastoma Risk Group Staging System (INRGSS) stage as assessed by 123I-MIBG and 18F-MFBG. II. To describe the natural history of discordant lesions detected only by 18F-MFBG and not by 123I-MIBG in patients with high-risk neuroblastoma, and to describe additional interventions undertaken (including additional imaging, biopsies, and/or additional therapies) based on identification of discordant lesions. III. To describe the change in standardized uptake value (SUV) of the primary and metastatic lesions on 18F-MFBG scans from diagnosis to end of induction. IV. To evaluate the patient/family experience with 123I-MIBG and 18F-MFBG imaging. V. To describe concordance between detection of disease using 123I-MIBG imaging (Curie score), 18F-MFBG imaging (Curie score) and the percentage of circulating tumor deoxyribonucleic acid (DNA) (as a continuous variable) testing during high-risk neuroblastoma therapy. VI. To identify logistical barriers to successful imaging using 18F-MFBG. VII. To quantify inter-observer variability of Curie scores on 18F-MFBG and 123I-MIBG among central reviewers. VIII. To describe acute toxicity of 18F-MFBG administration. IX. To estimate the progression free survival (PFS) and overall survival (OS) among eligible patients enrolled on the study. OUTLINE: Patients receive 18F-MFBG intravenously (IV) over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each standard of care (SOC) 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression). Patients may undergo blood sample collection throughout the study.