Actively Recruiting
68Ga-FAPI-Biotin PET/CT Imaging Compared to 68Ga-FAPI or 18F-FDG in Patients With Various Types of Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-12-18
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
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 PET/CT 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 PET/CT 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 90 years
- Diagnosed with various solid tumors confirmed by histopathology
- Signed informed consent to participate
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe liver insufficiency
- Severe kidney 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 - Single day
Participants receive one intravenous injection of either 68Ga-FAPI-Biotin or 68Ga-FAPI/18F-FDG tracer to detect tumors by PET/CT scanning.
1 visit (in-person)
Duration - Up to 3 months
Participants are monitored for approximately 3 months to evaluate diagnostic value and tumor characteristics after imaging.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Actively Recruiting
Research Team
W
Weibing Miao, MD
R
Rong Lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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