跳至主要内容
临床试验/NCT01234363
NCT01234363Unknown不适用

Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance

研究概览

简要总结

The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

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

  • Renal allograft performed less than 3 months before enrolment

排除标准

  • Contra-indication to magnetic resonance imaging
  • Contra-indication to biopsy

研究组 & 干预措施

Magnetic Resonance Elastography, Supersonic Shear Imaging

Experimental

Magnetic Resonance Elastography and Supersonic Shear Imaging

干预措施: Magnetic Resonance Elastography, and Supersonic Shear Imaging (Device)

结局指标

主要结局

Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance

时间窗: 3 months and 12 months after graft

次要结局

  • Correlation between elasticity and arterial resistance index(3 months and 12 months after graft)
  • Number of technical failures(12 months)
  • Tolerance (assessed by a questionnaire)(3 months and 12 months after graft)
  • Evolution of the elasticity of the transplant between 3 and 12 months after graft(3 months and 12 months after graft)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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