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

Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma

This study tests whether combining 123I‑MIBG SPECT/CT and somatostatin receptor PET improves detection, staging, and identification of PRRT candidates among children with suspected or confirmed neuroblastoma.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07064746 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 0–18 years with histologically confirmed or highly suspected neuroblastoma, at least one measurable lesion on CT/MRI, acceptable organ function, ECOG 0–2, and informed consent are eligible.

Not a fit: Patients who are pregnant or lactating, have severe organ dysfunction, known severe allergy to tracers, recent high‑dose therapy or radionuclide treatment, or unresolved bone marrow suppression are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, combining these imaging methods could improve detection and staging of neuroblastoma and help identify children who might benefit from PRRT.

How similar studies have performed: MIBG imaging is well established for neuroblastoma and emerging data suggest SSTR PET can detect MIBG‑negative lesions and aid PRRT selection, but the combined prospective application in a Chinese pediatric population is relatively novel.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Guoqiang Shao, Dr

Conditions Neuroblastoma; neuroblastoma; SSTR; MIBG; PET