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

Sponsor
Nanjing First Hospital, Nanjing Medical University
Study ID
NCT07195500
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

First listed
Sep 26, 2025
Start date
Dec 25, 2024
Status verified
Aug 2025
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Neuroblastoma and PPGL Patients Undergoing SSTR/NET Imaging
    This cohort includes patients with suspected or confirmed neuroblastoma (NB) or pheochromocytoma/paraganglioma (PPGL) undergoing somatostatin receptor (SSTR) and/or norepinephrine transporter (NET)-targeted molecular imaging for diagnostic evaluation and staging. Interventions of interest are diagnostic radiopharmaceutical administrations followed by imaging-there is no therapeutic intent. Participants may receive one or more NET tracers, including 18F-MFBG, 123I-MIBG, 131I-MIBG (legacy diagnostic where appropriate), 18F-LMI1195, and/or SSTR tracers, including 68Ga-DOTATATE, 68Ga-DOTATOC, 68Ga-DOTANOC, 64Cu-DOTATATE, 18F-SiTATE, 18F-AlF-NOTA-octreotide, depending on clinical indication and site availability. Imaging is performed on PET/CT or PET/MRI for PET tracers and SPECT/CT for SPECT tracers using harmonized acquisition and reconstruction parameters. When clinically justified

Primary Outcome Measure

SUVmax [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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