Actively Recruiting
68Ga-DOTA-NI-FAPI04 PET/CT Imaging Study in Patients With Various Types of Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-06-12
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic performance of a new radiotracer called 68Ga-DOTA-NI-FAPI04 in patients with various types of cancer. This tracer targets fibroblast activation protein (FAP), which is highly expressed in tumors but limited in normal tissues. The study compares 68Ga-DOTA-NI-FAPI04 PET/CT imaging results with those from other PET/CT tracers like 68Ga-FAPI and 18F-FDG to see how well it detects tumors. Participants receive an intravenous injection of either 68Ga-DOTA-NI-FAPI04 at a dose of 111-148 MBq (3-4 mCi) or a dose of 68Ga-FAPI or 18F-FDG (111-148 MBq for 68Ga-FAPI or 3.7 MBq/kg for 18F-FDG). These tracer doses are used to detect tumors through PET/CT scans. The trial is randomized and open-label, meaning participants are assigned to one of these groups without blinding. During the study, participants undergo PET/CT imaging to assess tumor detection and uptake values. The primary outcome measure is the diagnostic value of the imaging over about three months. Secondary outcomes include measuring the standardized uptake value (SUV) of tumors. The study runs from April 2024 to December 2025, with safety and diagnostic performance monitored throughout.
CONDITIONS
Brief Title
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with various solid tumors confirmed by histopathology
- Signed informed consent to participate in the study
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe liver (hepatic) insufficiency
- Severe kidney (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 - Single day
Participants receive a single intravenous injection of either 68Ga-DOTA-NI-FAPI04 or 68Ga-FAPI/18F-FDG tracer to detect tumors by PET/CT imaging.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo PET/CT imaging to evaluate tumor detection and diagnostic performance of the tracer.
Follow-up visits as scheduled to assess diagnostic results
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Actively Recruiting
Research Team
W
Weibing Miao, MD
G
Guochang Wang, 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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