NCT07064746 Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
| NCT ID | NCT07064746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Neuroblastoma (NB) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-07-10 |
| Primary Completion | 2027-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-07-10 with a primary completion date of 2027-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Ages 0-18 years, any sex 2. Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment 3. At least one measurable lesion on conventional imaging such as CT or MRI 4. ECOG performance status 0-2 and an expected survival of ≥3 months 5. 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 6. Informed consent signed by the subject or legal guardian Exclusion Criteria: 1. Known history of severe allergy to the radioactive isotope or molecular probe components to be used; 2. Pregnancy or lactation; 3. Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks; 4. Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection; 5. Bone marrow suppression not yet recovered (Hb \< 90 g/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L); 6. Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min); 7. Any other situation deemed inappropriate for enrollment by the investigator.
Contact & Investigator
Guoqiang Shao, Dr
STUDY CHAIR
Nanjing First Hospital, Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07064746 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Neuroblastoma (NB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07064746 currently recruiting?
Yes, NCT07064746 is actively recruiting participants. Contact the research team at guoqiangshao@163.com for enrollment information.
Where is the NCT07064746 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07064746 clinical trial?
NCT07064746 is sponsored by Nanjing First Hospital, Nanjing Medical University. The principal investigator is Guoqiang Shao, Dr at Nanjing First Hospital, Nanjing Medical University. The trial plans to enroll 150 participants.