RecruitingNCT07195500

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

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


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

30 participants

Start Date

Dec 25, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This study is comparing different types of nuclear medicine imaging scans — ones that target two specific receptors (somatostatin receptors and norepinephrine transporters) on tumor cells — to better diagnose and stage neuroblastoma (a childhood cancer) and pheochromocytoma/paraganglioma (rare tumors of nerve tissue in adults and children). **You may be eligible if...** - You are 6 months of age or older (children and adults) - You have a suspected or confirmed diagnosis of neuroblastoma, pheochromocytoma, or paraganglioma - A doctor has determined you need this type of imaging for diagnosis, staging, restaging, or treatment planning - You are able to undergo PET/CT or PET/MRI or SPECT/CT imaging - Female participants of childbearing potential must have a negative pregnancy test prior to imaging **You may NOT be eligible if...** - You are younger than 6 months old - You have MRI contraindications (for the MRI-based imaging subset) - You are pregnant and do not meet safety criteria for the imaging agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT07195500


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