NCT07064746Recruiting
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Source: ClinicalTrials.gov · Last updated 21 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 6 Jul 2025
- Start date
- 10 Jul 2022
- Primary completion date
- 10 Jul 2027
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT07064746
What you commit to
- Study type: Observational
- Planned participants: 150
- From 10 Jul 2022 to the primary completion date, 10 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
Other illness
- Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
- Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
Lab values
- Bone marrow suppression not yet recovered (Hb \< 90 g/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L);
Other
- Pregnancy or lactation;
- Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min);
- Any other situation deemed inappropriate for enrollment by the investigator.
Who the study is looking for
- 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
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.