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临床试验/NCT06563765
NCT06563765Enrolling By Invitation不适用

FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月10日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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