Nanjing First Hospital, Nanjing Medical University
Phase
Observational
Started
2022-07-10
Last updated
2025-07-21
Condition(s) studied
Neuroblastoma (NB)
Investigational drug(s) / intervention(s)
¹²³I-MIBG SPECT/CTSSTR PET
¹²³I-MIBG SPECT/CT: Patients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.
SSTR PET: Patients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for \~20 min; MRI or CT provides attenuation correction. Sedation used when required.
Study 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
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
SUVmean — baseline and 6 months SUVmean is obtained by outlining a 3-D volume-of-interest around the lesion on attenuation-corrected PET images and averaging all voxel values. Standardized uptake values are calculated as voxel activity concentration (kBq/mL) divided by injected activity per body weight (kBq/g).
SUVmax — Baseline and 6 months SUVmax is obtained by outlining a 3-D volume of interest (VOI) around the lesion on attenuation-corrected PET images; the software reports the single voxel with the highest activity concentration, normalized to injected tracer dose divided by the patient's body weight (MBq/kg).
SUVpeak — baseline and 6 months SUVpeak is obtained by drawing a fixed-size, 1 cm³ spherical volume of interest centered on the hottest voxel within the tumor on attenuation-corrected PET images; the mean activity concentration inside this sphere is normalized to injected dose per body weight to yield SUVpeak, minimizing noise while reflecting maximal metabolic activity.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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