Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
NCT07195500 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-09-26
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
Conditions
- Neuroblastoma
- Pheochromocytoma
- Paraganglioma
Sponsors & Collaborators
-
Nanjing First Hospital, Nanjing Medical University
lead OTHER
Principal Investigators
-
Guoqiang Shao, Dr · Nanjing First Hospital, Nanjing Medical University
Eligibility
- Min Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-25
- Primary Completion
- 2027-12-30
- Completion
- 2028-06-30
Countries
- China
Study Locations
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