Actively Recruiting
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-07-21
150
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
J
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 0 to 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 to 2 and expected survival of 3 months or more
- Hematologic, liver, and kidney function meeting: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, creatinine ≤ 1.5 × ULN
- Signed informed consent by the patient or legal guardian
You will not qualify if you...
- Severe allergy to radioactive isotopes or molecular probe components
- Pregnancy or breastfeeding
- High-dose chemotherapy, radiotherapy, radionuclide therapy, or participation in other interventional trials within 4 weeks
- Severe or uncontrolled heart, lung, liver, or kidney failure, or active severe infection
- Bone marrow suppression not recovered (Hb < 90 g/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L)
- Unable to complete PET/CT imaging (e.g., severe claustrophobia, inability to lie still for 30 minutes)
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
G
Guoqiang Shao, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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