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

Recruiting

• Conditions: 18F-FAPI PET/CT Examination; Renal Puncture Biopsy
• Interventions: Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination; Procedure: Renal puncture biopsy

• Registration Number: NCT05752097
• Lead Sponsor: Sichuan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-08-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal inflammatory or fibrotic disease	Renal puncture biopsy	\[18F\]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.
Renal inflammatory or fibrotic disease	[18F]AlF-NOTA-FAPI-04 PET/CT examination	\[18F\]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.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value	30minutes after PET/CT examination	The extent of renal uptake of FAPI

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China