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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases

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

Intervention / Treatment
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* Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination
* Procedure: Renal puncture biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal inflammatory or fibrotic disease<br>[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. | Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination<br>* The intravenous radiotracer dose is 1.85-2.59 MBq/kg, and imaging will be performed 50-60 min after radiotracer injection. All patients are required to urinate as much as possible for imaging preparations, which reduces the influence of the residual radiotracer in the renal pelvis and calyces. Some patients with poor renal function (GFR<60 mL/min, urine volume < 1000 mL/24 h) will be given diuretics (Furosemide, 0.57 mg/kg). The scope of the whole-body inspection is from the base of the skull to the base of the thigh, using five to six beds (3 min/bed). The matrix was 128×128, the PET layer thickness was 3 mm, and all PET images are reconstructed iteratively.<br>Procedure: Renal puncture biopsy<br>* The patients undergo renal puncture biopsy one day after PET/CT examination. Pathological results of renal biopsy will be collected after surgery, including but not limited to: pathological diagnosis, proportion of glomerulosclerosis, extent of inflammatory cell infiltration, and degree of renal interstitial fibrosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value | The extent of renal uptake of FAPI | 30minutes after PET/CT examination |