MIBG SPECT/CT and somatostatin receptor PET for diagnosing and staging neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study in which children (≤18 years) with suspected or confirmed neuroblastoma receive both 123I‑MIBG SPECT/CT and somatostatin receptor (SSTR) PET as part of routine evaluation. Imaging results will be compared with histopathology, clinical course, and up to 24 months of follow-up to determine sensitivity and specificity for initial staging and for detecting relapse or metastasis. A key aim is to see if SSTR PET finds lesions that are negative on MIBG and thereby helps select candidates for peptide‑receptor radionuclide therapy (PRRT). The study is conducted at Nanjing First Hospital with standardized imaging protocols and centralized correlation of imaging with clinical outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Guoqiang Shao, Dr
• Email: guoqiangshao@163.com
• Phone: +86 153 6615 5689

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.