Actively Recruiting
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
Led by Peking Union Medical College Hospital · Updated on 2026-03-11
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of [68Ga] Ga-NI-FAPI-04 PET/CT imaging to better understand its value in diagnosing diseases related to fibroblast activation, including tumors, cardiovascular diseases, pulmonary fibrosis, rheumatic immune diseases involving large blood vessels, hypertrophic cardiomyopathy, and other hypoxic and fibroblast-activated conditions. This study is a Phase 1 and Phase 2 clinical trial sponsored by Peking Union Medical College Hospital. Participants will receive an injection of 68Ga-NI-FAPI at a dose of 0.4-0.5 mCi per kilogram of body weight. After the injection, PET/CT images will be analyzed within 30 to 120 minutes to assess the imaging agent's diagnostic capabilities. The study involves only one experimental group receiving this imaging agent. During the trial, participants will undergo PET/CT scans and image analysis to evaluate the diagnostic value of the imaging agent. Eligible participants include patients with tumors who can obtain pathological diagnosis through surgery or biopsy, as well as healthy volunteers without chronic diseases. The study includes monitoring for safety and follow-up over a period that meets the expected survival time of patients. The total participation duration will vary depending on individual follow-up needs but includes image analysis shortly after injection.
CONDITIONS
Brief Title
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years old
- Tumor patients able to undergo surgery or biopsy for pathological diagnosis
- Ability to understand and sign informed consent forms
- Expected survival period exceeding 6 months and able to receive follow-up
- Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, and similar conditions
You will not qualify if you...
- Pregnant or lactating women
- Patients allergic to ingredients of the research drug
- Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 bc mol/L)
- Patients participating in other clinical trials that may interfere with this study
- Patients with severe illness who cannot cooperate with examinations
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 - Within 2 hours on the day of injection
Participants receive an injection of 68Ga-NI-FAPI followed by PET/CT imaging to analyze fibroblast activation protein-related diseases.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Z
Zhu
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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