NCT05752097RecruitingNot Applicable
Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases
Sichuan Provincial People's Hospital1 site in 1 country30 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Standardized uptake value
Study Overview
Brief Summary
The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are:
- Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease?
- What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive [18F]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The pitients of nephritis or fibrosis disease
Exclusion Criteria
- •Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
- •Renal biopsy cannot be performed for severe exclotting disease
- •Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
- •Unable to cooperate with renal puncture biopsy due to language communication or other problems
- •Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
- •Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
- •Alcohol allergy
- •Patients with significant decrease in urine volume due to disease
- •Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol
- •Other circumstances deemed inappropriate by the investigator for participation in the study.
Outcomes
Primary Outcomes
Standardized uptake value
Time Frame: 30minutes after PET/CT examination
The extent of renal uptake of FAPI
Secondary Outcomes
No secondary outcomes reported
Investigators
Hao Wang
Principal Investigator
Sichuan Provincial People's Hospital
Study Sites (1)
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