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

NCT07064746 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-07-21

No results posted yet for this study

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.

Conditions

  • Neuroblastoma (NB)

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.

Sponsors & Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Guoqiang Shao, Dr · Nanjing First Hospital, Nanjing Medical University

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-10
Primary Completion
2027-07-10
Completion
2027-07-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064746 on ClinicalTrials.gov