Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Im… (NCT07064746) | Clinical Trial Compass
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Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
China150 participantsStarted 2022-07-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
✕. Pregnancy or lactation;
✕. Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
What they're measuring
1
SUVmean
Timeframe: baseline and 6 months
2
SUVmax
Timeframe: Baseline and 6 months
3
SUVpeak
Timeframe: baseline and 6 months
Trial details
NCT IDNCT07064746
SponsorNanjing First Hospital, Nanjing Medical University