Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma

The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT/CT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). The main questions it aims to answer are: * What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis? * Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)? Pediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.

NCT Number	NCT07064746
Lead Sponsor	Nanjing First Hospital, Nanjing Medical University Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine
Conditions	Neuroblastoma (NB)
Enrollment	150 participants
Start Date	2022-07-10
Primary Completion	2027-07-10 (estimated)
Study Completion	2027-07-10 (estimated)
Updated on ClinicalTrials.gov	2025-07-21