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临床试验/NCT05036759
NCT05036759Unknown早期 1 期

68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
试验地点
1
主要终点
Diagnostic performance

研究概览

简要总结

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

详细描述

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • intracranial or carotid atherosclerosis patients
  • signed informed consent

排除标准

  • pregnancy, breastfeeding
  • contradictions of MRI
  • unstable vital signs

研究组 & 干预措施

68Ga-FAPI, PET/MR

Experimental

inject 68Ga-FAPI,and then perform PET/MR

干预措施: 68Ga-FAPI (Drug)

结局指标

主要结局

Diagnostic performance

时间窗: through study completion, an average of 2 years

Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis

次要结局

  • SUVmax(through study completion, an average of 2 years)
  • FAPI expression(through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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