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Study of 68Ga-FAPI-Biotin PETCT Imaging Compared to 68Ga-FAPI and 18F-FDG in Adults With Various Solid Tumors
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-12-18
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent called 68Ga-FAPI-Biotin in patients with various types of cancer. This tracer targets fibroblast activation protein FAP and biotin, which are highly expressed in many tumors, to improve tumor detection. The study compares 68Ga-FAPI-Biotin with existing imaging agents 68Ga-FAPI and 18F-FDG to assess safety, biodistribution, radiation dose, and diagnostic effectiveness. Participants receive a single intravenous dose of 68Ga-FAPI-Biotin or a comparator tracer 68Ga-FAPI or 18F-FDG to detect tumors using PETCT scans. The doses range from 111 to 148 MBq for 68Ga-FAPI-Biotin and 68Ga-FAPI, or 3.7 MBq per kilogram for 18F-FDG. This early phase 1 trial involves randomized assignment to one of these tracer groups for direct comparison. During the study, participants undergo PETCT imaging to observe tracer distribution and tumor uptake. Researchers measure diagnostic value and tumor standardized uptake values SUV over about three months. Safety and radiation exposure are also monitored. The trial is sponsored by the First Affiliated Hospital of Fujian Medical University and includes adults aged 18 to 90 years with solid tumors confirmed by pathology.
CONDITIONS
Brief Title
68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer
Research Team
W
Weibing Miao, MD
R
Rong Lin, MD
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