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临床试验/NCT03918161
NCT03918161已完成不适用

Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Mean value of renal elasticity

研究概览

简要总结

: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.

The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.

详细描述

The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss.

Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA.

Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures.

The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft.

The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy.

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

入选标准

  • Age ≥ 18yrs;
  • Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
  • Signed informed consent;
  • Affiliated or beneficiary of health insurance

排除标准

  • Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler;
  • Pregnant or nursing women;
  • Contraindications to MRI;
  • Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent

研究组 & 干预措施

MRE exam

Experimental

Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences

干预措施: MRE exam (Device)

结局指标

主要结局

Mean value of renal elasticity

时间窗: Baseline (defined as during MRE exam)

5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)

次要结局

  • Average value of renal elasticity(Baseline (defined as during MRE exam))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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