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;
Target population * Consecutively enrolled neuroblastoma (NB) patients aged 0-18 years, of any sex; * Inclusive of all INSS stages Ⅰ-ⅣS and risk groups (low, intermediate, high), covering newly diagnosed, relapsed, and refractory cases; * Pathologically confirmed NB, or highly suspected NB based on characteristic imaging plus elevated urinary VMA/HVA, with at least one measurable lesion on routine CT/MRI; * Primary and metastatic cases (bone, bone marrow, liver, lymph nodes, etc.) at different treatment stages (before treatment, during treatment, follow-up) are allowed to ensure representativeness in age, sex, histology, stage, and metastatic site distribution.
Cohort
Prospective
¹²³I-MIBG SPECT/CT
Diagnostic testPatients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.
SSTR PET
Diagnostic testPatients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for \~20 min; MRI or CT provides attenuation correction. Sedation used when required.
SUVmean
SUVmean is obtained by outlining a 3-D volume-of-interest around the lesion on attenuation-corrected PET images and averaging all voxel values. Standardized uptake values are calculated as voxel activity concentration (kBq/mL) divided by injected activity per body weight (kBq/g).
SUVmax
SUVmax is obtained by outlining a 3-D volume of interest (VOI) around the lesion on attenuation-corrected PET images; the software reports the single voxel with the highest activity concentration, normalized to injected tracer dose divided by the patient's body weight (MBq/kg).
SUVpeak
SUVpeak is obtained by drawing a fixed-size, 1 cm³ spherical volume of interest centered on the hottest voxel within the tumor on attenuation-corrected PET images; the mean activity concentration inside this sphere is normalized to injected dose per body weight to yield SUVpeak, minimizing noise while reflecting maximal metabolic activity.
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Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
