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RECRUITING
NCT07064746

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

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2022-07-10

Completion Date

2027-07-10

Last Updated

2025-07-21

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

¹²³I-MIBG SPECT/CT

Patients 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.

DIAGNOSTIC_TEST

SSTR PET

Patients 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.

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China