Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The values and correlation of f with IF
研究概览
简要总结
The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).
详细描述
The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •Age 18-80 years
- •Recipient of living donor kidney transplantation 4 or 7 years earlier
- •Competent and able to provide written informed consent; Ability to comply with protocol
排除标准
- •Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- •Severe chronic liver, heart or lung disease
- •Undergoing acute rejection
- •Contra-indication to biopsy; bleeding disorders
- •Chronic infection
- •Any active malignancy and undergoing therapy
- •Kidney or ureteric stone
- •Unable to give valid informed consent
- •Known pregnancy or intent to conceive during the study period
- •Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI
- •Federal medical center inmates.
- •Latex allergy
结局指标
主要结局
The values and correlation of f with IF
时间窗: 2 years
Correlation of qMT with tissue fibrosis (trichrome)
次要结局
- The correlation of f with renal function attributes and pro-fibrogenic activity(2 years)
研究者
Lilach O Lerman
Principal Investigator
Mayo Clinic