FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pathological type
研究概览
简要总结
Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease
- •Renal pathology was performed within 2 weeks
排除标准
- •Pregnant or lactating patients
研究组 & 干预措施
FAP-targeting PET/CT imaging
FAP-targeting PET/CT imaging will be performed on the enrolled patients.
干预措施: FAP-targeting PET/CT imaging will be performed on the enrolled patients. (Other)
结局指标
主要结局
Pathological type
时间窗: 1 week after enrollment
pathological type (e.g., sclerosing IgA nephropathy)
Pathological MESTC score
时间窗: 1 week after enrollment
MESTC score (0-2, for IgA nephropathy patients)
Baseline serum creatinine (μmol/L)
时间窗: 1 month before enrollment and 1 month after enrollment
laboratory results
Baseline 24-hour urinary protein (g/24h)
时间窗: 1 month before enrollment and 1 month after enrollment
laboratory results
Quantified renal pathological involvement.
时间窗: 1 week after enrollment
Based on kidney biopsy sections, interstitial atrophy, interstitial inflammatory infiltration, and tubular fibrosis will be quantified.
次要结局
- Follow-up serum creatinine (μmol/L)(From 1 month after enrollment to 60 month after enrollment)
- Proteinuria remisssion(From 1 month after enrollment to 60 month after enrollment)
- Acute kidney disease remission(Within 3 month after enrollment)
