[68Ga]Ga-DOTA-TOC positron emission tomography outperforms [18F]FDOPA and [18F]FDG PET in pediatric neuroblastoma imaging: a prospective study.
Chia-Ju Liu, Kuan-Yin Ko, Meng-Yao Lu...
https://pubmed.ncbi.nlm.nih.gov/40512254/Actively Recruiting
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-09-26
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the use of specialized molecular imaging techniques that target somatostatin receptors and norepinephrine transporters to diagnose and stage neuroblastoma and pheochromocytomaparaganglioma in patients aged 6 months to 70 years. These methods include various radioactive tracers such as 18F-MFBG, 123I131I-MIBG, and 68Ga-labeled peptides, aiming to determine their accuracy compared to the standard surgical pathology results. The study is observational and focuses on improving detection and treatment planning for these tumors. Participants will receive intravenous injections of selected tracers followed by PETCT, PETMRI, or SPECTCT imaging, depending on the tracer used and patient suitability. The choice of tracer is personalized based on clinical factors, and some patients may undergo multiple tracer imaging within a short timeframe to allow direct comparison. Optional imaging with FDG and CXCR4-targeted agents may also be performed. The study includes standardized imaging acquisition, quantitative analysis, and comparison with histopathology and clinical follow-up as reference standards. During the study, participants will undergo initial assessments including medical history, physical exams, and lab tests. Imaging is performed at optimized times post-injection, followed by histopathological examination within two months. Safety is monitored for six months after imaging to track any adverse effects. Researchers will measure imaging parameters such as SUVmax and SUVmean, evaluate diagnostic accuracy and inter-reader agreement, and ensure radiation exposure stays within recommended levels. Data management follows strict quality and regulatory standards throughout the study duration, which extends up to one year on average per participant.
CONDITIONS
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
G
Guoqiang Shao, Dr
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Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 28 days for multi-tracer comparisons
Participants undergo somatostatin receptor (SSTR) and norepinephrine transporter (NET) targeted molecular imaging to detect and stage neuroblastoma or pheochromocytoma/paraganglioma. Imaging is performed using PET/CT, PET/MRI, and/or SPECT/CT with one or more radiotracers selected based on clinical indication and site availability.
1 to 2 imaging visits depending on tracer selection
Duration - Through study completion, approximately 1 year
Participants are observed through clinical follow-up and imaging for approximately 1 year to assess diagnostic accuracy, quantitative imaging metrics, and comparative performance between tracer classes.
Follow-up visits as clinically indicated
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor