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临床试验/NCT03705091
NCT03705091Unknown不适用

Non Contrast Magnetic Resonance Imaging to Measure Renal Transplant Perfusion and Fibrosis - Association With Function and Prognosis

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Change in arterial spin labelling (ASL)

研究概览

简要总结

Renal transplantation is the optimal method of treatment for end stage kidney disease however median lifespan of a kidney transplant is around 15 years. Existing methods of measuring transplant function and structure from blood and urine markers are imperfect; renal biopsy is often performed but is invasive. Novel methods of investigating transplant function are therefore required and emerging renal MRI sequences including ASL and diffusion weighted imaging may yield helpful biomarkers. Investigators will recruit 20 patients in the first year after transplant and measure MRI biomarkers at three time points, with correlation to existing methods of measuring transplant function.

详细描述

Kidney transplantation remains the optimal therapy for patients with end stage kidney disease and is associated with significant improvements in life expectancy and quality of life compared to subjects receiving dialysis. Despite significant advances in our understanding of the immune system and development of drugs to prolong transplant function, a large number (Scottish Renal Registry data suggest between 23-35%) of transplants fail in the 10 years from operation. This may be due to a number of factors but is often due to development of transplant rejection, where the recipient's immune system damages the transplant. Early recognition and implementation of therapy is needed to dampen this response, reduce irreversible damage and preserve transplant function.

At present, transplant function and damage is measured using blood and urine tests. These are far from perfect markers because there is a delay between transplant damage and abnormalities of these tests. This time is vital for the short and long term survival of the transplant.

In the University of Glasgow, investigators have developed a new type of magnetic resonance imaging (MRI) which allows assessment of kidney blood flow and fibrosis (scarring) without the need for administration of harmful contrast agents. Arterial spin labelling magnetic resonance imaging (ASL MRI) is a non-invasive method of measuring renal perfusion using magnetised blood as endogenous contrast and investigators have validated this technique previously in both individuals with and without kidney disease. Diffusion tensor imaging (DTI) is another modality of non-contrast MRI which allows measurement of 'stiffness' of renal transplants, which represents long term scarring and fibrosis.

The investigators intend to follow up people receiving a kidney transplant for one year, collecting samples of blood, urine, and performing MR imaging at 3 time points, in order to investigate novel biomarkers of transplant function and dysfunction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Recent or pending kidney transplantation
  • Written informed consent

排除标准

  • Severe chronic liver, heart or lung disease
  • Chronic infection
  • Unable to give valid informed consent
  • Known pregnancy or intent to conceive during the study period
  • Any contraindicating to MRI

结局指标

主要结局

Change in arterial spin labelling (ASL)

时间窗: Measured at 2, 6, 12 months after transplant

Renal perfusion measured by ASL MRI

次要结局

  • Change in apparent diffusion coefficient (ADC)(Measured at 2, 6, 12 months after transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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