Compares two scan types for finding neuroblastoma in children
Tests two imaging scans in children with suspected or confirmed neuroblastoma.
Plain-language title generated from the registry record
Registry title: Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- Nanjing First HospitalNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing First Hospital, Nanjing Medical University
- Trial code
- NCT07064746
- Record updated
- 21 July 2025
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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; Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN; Informed consent signed by the subject or legal guardian.
Exclusion: Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks; Known history of severe allergy to the radioactive isotope or molecular probe components to be used; Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection; Bone marrow suppression not yet recovered (Hb < 90 g/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L); Pregnancy or lactation; Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min); Any other situation deemed inappropriate for enrollment by the investigator.