RecruitingNCT07064746

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

Enrollment

150 participants

Start Date

Jul 10, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two types of nuclear medicine imaging scans — MIBG scanning and somatostatin receptor imaging — in children and young adults with neuroblastoma (a childhood cancer that typically starts in the adrenal glands or nerve tissue) to improve how accurately the cancer is detected and staged. **You may be eligible if...** - You are between 0 and 18 years old - You have been diagnosed with neuroblastoma (confirmed by biopsy or strongly suspected on clinical grounds) and imaging is planned - You have at least one tumor visible on standard CT or MRI scans - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - You have a known severe allergy to the imaging agents used in this study - You are pregnant or breastfeeding - You recently received high-dose chemotherapy, radiation, or a prior nuclear medicine treatment that could interfere with the scan results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST¹²³I-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_TESTSSTR 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

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NCT07064746


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