Actively Recruiting
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-09-26
30
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 months or older (pediatric and adult)
- Suspected or confirmed diagnosis of neuroblastoma or pheochromocytoma/paraganglioma
- Clinical need for somatostatin receptor and/or norepinephrine transporter imaging for staging, restaging, recurrence, response assessment, or treatment planning
- Ability to undergo PET/CT, PET/MRI, or SPECT/CT scans as required by the protocol
- Written informed consent or assent given according to local rules
- For women able to have children: negative pregnancy test within 72 hours before tracer injection and agreement to use effective contraception during imaging
- Willingness to have two imaging studies within about 28 days without cancer treatment in between (if participating in multi-tracer imaging)
You will not qualify if you...
- Pregnant or breastfeeding, or unwilling to follow lactation guidelines for tracer use
- Any condition that makes safe imaging or following the study rules impossible, such as uncontrolled heart or lung disease or severe claustrophobia not manageable by sedation
- Known allergy to study imaging agents or their ingredients
- Use of medications that interfere with catecholamine transport for norepinephrine transporter imaging without possible washout
- Recent use of long-acting somatostatin analogues within about 3-4 weeks or short-acting within about 24-48 hours unless unavoidable
- Prior high-dose 131I-MIBG therapy within about 6 months that could affect imaging
- Contraindications to required imaging procedures, such as MRI-incompatible implants or contrast allergies if contrast is needed
- Inability to stay still for imaging with no option for sedation
- Participation in other cancer treatment studies or receipt of anticancer therapy that could interfere with imaging during the study period; no systemic therapy allowed between scans for multi-tracer comparisons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
G
Guoqiang Shao, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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