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Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
ID06734572

Study of 18F-FAPI-Biotin PETCT Imaging to Assess Dosimetry and Distribution in Adults With Various Solid Tumors

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-12-16

5

Participants Needed

1

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new dual targeting PET radiotracer called 18F-FAPI-Biotin in patients with various types of cancer. This tracer aims to improve tumor detection by targeting both fibroblast activation protein, which is highly expressed in many cancer stromas, and biotin, which is overexpressed in tumor cells but underexpressed in normal cells. The study focuses on assessing the safety, how the tracer distributes in the body, and the radiation dosimetry compared to existing tracers like 18F-FAPI and 18F-FDG. Participants receive an intravenous dose of 148-296 MBq of 18F-FAPI-Biotin. PET imaging is conducted dynamically at multiple time points 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 120 minutes after injection. This allows researchers to observe the tracers pharmacokinetics and dosimetry across different organs and tumors. The study is classified as an early phase 1 trial. During the study, patients undergo PETCT scans at the specified time points following tracer injection. Researchers monitor the dosimetry of normal organs and tumors from immediately after injection up to 120 minutes later. Safety assessments include tracking adverse events for up to one week using standard criteria. The total participation duration includes imaging sessions and safety monitoring to evaluate the tracers distribution and potential side effects.

CONDITIONS

Brief Title

18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study

Research Team

W

Weibing Miao, MD

R

Rong Lin, MD

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