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

NCT07064746 | Recruiting DMC

• 1 other identifier: KY20220701-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma (NB)

Keywords

neuroblastoma; SSTR; MIBG; PET

Outcome Measures

Primary Outcomes (3)

• SUVmean

  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).

  baseline and 6 months

• SUVmax

  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).

  Baseline and 6 months

• SUVpeak

  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.

  baseline and 6 months

Study Arms (1)

Pediatric Neuroblastoma Imaging Cohort

This cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT for staging, therapy planning, and disease monitoring.

Diagnostic Test: ¹²³I-MIBG SPECT/CT; Diagnostic Test: SSTR PET

Interventions

¹²³I-MIBG SPECT/CT DIAGNOSTIC_TEST

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.

Pediatric Neuroblastoma Imaging Cohort

SSTR PET DIAGNOSTIC_TEST

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.

Pediatric Neuroblastoma Imaging Cohort

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Target population * Consecutively enrolled neuroblastoma (NB) patients aged 0-18 years, of any sex; * Inclusive of all INSS stages Ⅰ-ⅣS and risk groups (low, intermediate, high), covering newly diagnosed, relapsed, and refractory cases; * Pathologically confirmed NB, or highly suspected NB based on characteristic imaging plus elevated urinary VMA/HVA, with at least one measurable lesion on routine CT/MRI; * Primary and metastatic cases (bone, bone marrow, liver, lymph nodes, etc.) at different treatment stages (before treatment, during treatment, follow-up) are allowed to ensure representativeness in age, sex, histology, stage, and metastatic site distribution.

You may qualify if:

• 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

You may not qualify if:

• Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
• Pregnancy or lactation;
• Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
• Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
• Bone marrow suppression not yet recovered (Hb \< 90 g/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L);
• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Guoqiang Shao, Dr

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Guoqiang Shao, Dr

CONTACT

+86 153 6615 5689; guoqiangshao@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 15, 2025
• Study Start: July 10, 2022
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2027
• Last Updated: July 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 6 months and ending 3 years after the publication of results
• Access Criteria: Qualified academic investigators with an IRB-approved proposal may request access to de-identified individual participant data (IPD), the full study protocol, blank case report forms, and the English/Chinese informed-consent templates. Requests should be emailed to the corresponding author; after signing a data-sharing agreement, files will be shared through a secure, password-protected institutional repository within 30 days.

Locations

CN (1)