[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases

Sichuan Provincial People's Hospital

Status: Enrolling

Conditions: Renal Puncture Biopsy; 18F-FAPI PET/CT Examination

Treatments: Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination; Procedure: Renal puncture biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05752097

SCPHNM

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Renal inflammatory or fibrotic disease

Description:

\[18F\]AIF-NOTA-FAPI-04 (4.81MBq/Kg) will be injected intravenously according to the patient's body weight. PET/CT examination will be performed 50-60 minutes after the injection of radiotracer. The patients will undergo renal puncture biopsy one day after PET/CT examination.

Treatment:

Procedure: Renal puncture biopsy

Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination