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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
Guoqiang Shao, Dr
guoqiangshao@163.com
+86 153 6615 5689
Time Frame
Start Date: 2022-07-10
Estimated Completion Date: 2027-07-10
Participants
Target number of participants: 150
Treatments
Pediatric Neuroblastoma Imaging Cohort
This cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT for staging, therapy planning, and disease monitoring.
Sponsors
Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov