NCT05752097招募中不适用
Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases
Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The pitients of nephritis or fibrosis disease
排除标准
- •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.
结局指标
主要结局
Standardized uptake value
时间窗: 30minutes after PET/CT examination
The extent of renal uptake of FAPI
次要结局
未报告次要终点
研究者
Hao Wang
Principal Investigator
Sichuan Provincial People's Hospital
研究点 (1)
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