Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma

NCT07195500 · tracked via the Priya Life Science China tracker

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Observational

Started

2024-12-25

Last updated

2025-09-26

Condition(s) studied

NeuroblastomaPheochromocytomaParaganglioma

Study summary

The goal of this clinical trial is to evaluate the diagnostic efficacy of somatostatin receptor and norepinephrine transporter targeted imaging (including 18F-MFBG, 123I-MIBG, 131I-MIBG, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, 68Ga-DOTA-TOC, and other radiolabeled somatostatin analogues) in the diagnosis and staging of neuroblastoma and pheochromocytoma/paraganglioma patients aged 1-70 years. The main questions it aims to answer are:

Can molecular targeted imaging using various norepinephrine transporter tracers (18F-MFBG, 123I/131I-MIBG) and somatostatin receptor tracers (68Ga-DOTA-peptides series) accurately detect primary tumors and metastatic lesions in neuroblastoma/pheochromocytoma patients? What is the comparative diagnostic performance (sensitivity, specificity, accuracy) of different molecular imaging techniques compared to histopathological diagnosis as the gold standard? Researchers will compare the imaging findings from multiple tracer types with surgical pathology results to assess diagnostic accuracy and clinical staging precision.

Participants will:

* Undergo screening assessments including medical history, physical examination, and laboratory tests
* Receive intravenous injection of selected tracers (18F-MFBG, 68Ga-DOTA-NOC/TATE, or other appropriate agents) at standardized doses followed by PET-CT/MRI imaging at optimal time points
* Undergo histopathological examination within 2 months post-imaging
* Complete safety follow-up for 6 months to monitor for any adverse reactions to the imaging agents

Eligibility

Sex

ALL

Min age

6 Months

Max age

—

Healthy volunteers

Inclusion Criteria: * Age: ≥6 months (pediatric and adult). * Suspected or confirmed diagnosis of neuroblastoma (NB) or pheochromocytoma/paraganglioma (PPGL). * Clinical indication for SSTR and/or NET-targeted molecular imaging for initial staging, restaging, suspected recurrence, response assessment, or treatment planning. * Ability to undergo PET/CT or PET/MRI and/or SPECT/CT per protocol; for the PET/MRI subset, no MRI contraindications. * Provision of written informed consent/assent per local regulations. * Women of childbearing potential: negative pregnancy test within 72 hours prior to tracer administration and agreement to use effective contraception during the imaging window. * For the multi-tracer subset (if applicable): willingness to undergo two imaging studies within a predefined window (e.g., ≤28 days) without intervening antitumor therapy. Exclusion Criteria: * Pregnant or breastfeeding; breastfeeding participants unwilling to follow tracer-specific lactation interruption guidance per institutional policy. * Any condition that, in the investigator's judgment, precludes safe imaging or protocol compliance (e.g., uncontrolled cardiorespiratory disease, severe claustrophobia not amenable to sedation/anxiolysis). * Known hypersensitivity to study radiopharmaceuticals or their excipients. * Use of interfering medications without feasible washout: NET imaging: drugs that affect catecholamine transport/storage (e.g., labetalol, tricyclic antidepressants, certain sympathomimetics) per site SOPs. SSTR imaging: long-acting somatostatin analogues within \~3-4 weeks or short-acting within \~24-48 hours, unless clinically unavoidable. * Prior therapeutic or high-dose 131I-MIBG within a period that would confound diagnostic imaging or dosimetry (e.g., within 6 months), at the investigator's discretion. * Contraindications to required modality-specific procedures (e.g., MRI-incompatible implants for PET/MRI; iodinated/gadolinium contrast contraindication only if contrast is mandated and no alternative pathway is acceptable). * Inability to lie still for the required acquisition time and sedation not feasible per institutional policy. * Concurrent participation in an interventional study or receipt of anticancer therapy that would confound imaging interpretation within the imaging window; for multi-tracer comparisons, any interval systemic therapy between scans.

Primary outcome measure(s)

SUVmax — through study completion, an average of 1 year
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).
SUVmean — through study completion, an average of 1 year
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).
Diagnostic Accuracy of SSTR and NET-Targeted Imaging — through study completion, an average of 1 year
Per-patient and per-lesion sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy compared to composite reference standard (histopathology when available and/or multidisciplinary clinical adjudication) Area under the receiver operating characteristic curve (AUC-ROC) for quantitative uptake metrics (SUVmax, SUVmean, target-to-background ratios)
Comparative Diagnostic Performance Between Tracer Classes — through study completion, an average of 1 year
Head-to-head comparison of NET-targeted tracers (18F-MFBG, 123I-MIBG, others) versus SSTR-targeted tracers (68Ga-DOTA-peptides, 64Cu-DOTATATE, 18F-SSTR agents, others) in patients undergoing multi-tracer imaging Within-class comparative performance (e.g., 68Ga-DOTATATE vs 68Ga-DOTATOC vs 68Ga-DOTANOC; 18F-MFBG vs 123I-MIBG)

Trial sites (1)

Facility	City	Region	Status
Nanjing First Hospital	Nanjing	Jiangsu	Recruiting

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Official registry record

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.

View NCT07195500 on ClinicalTrials.gov ↗ ← All trials in China