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.
Ages 0-18 years, any sex
Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
At least one measurable lesion on conventional imaging such as CT or MRI
ECOG performance status 0-2 and an expected survival of ≥3 months
Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
Pregnancy or lactation;
Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator