Actively Recruiting
18F-FAPIBiotin PET/CT Dosimetry and Biodistribution Study in Patients With Various Cancers
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-12-16
5
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
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 tracer's pharmacokinetics and dosimetry across different organs and tumors. The study is classified as an early phase 1 trial. During the study, patients undergo PET/CT 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 tracer's distribution and potential side effects.
CONDITIONS
Brief Title
18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Various solid tumors with available histopathological findings
- Signed informed consent
- Age between 18 and 80 years
You will not qualify if you...
- Pregnant or lactational women
- Severe hepatic and renal insufficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours on the day of injection
Participants receive an intravenous injection of 18F-FAPIBiotin and undergo PET imaging at multiple time points to evaluate tracer distribution.
1 visit with imaging at 3, 15, 30, 60, and 120 minutes post-injection
Duration - Up to 1 week
Participants are monitored for any adverse events following the imaging procedure.
Follow-up contact(s) for safety monitoring
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
R
Rong Lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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