Comprehensive Morphological and Functional Assessment of Living Renal Donor With Magnetic Resonance Imaging With Comparison to Computed Tomographic Angiography and Renal Scintigraphy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Accuracy of MRI exam in kidney donors
研究概览
简要总结
Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and function is crucial to ensure optimal outcomes for both kidney donor and recipient in transplantation.
Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol exposes this relatively young and healthy population to a high radiation dose and potentially nephrotoxic contrast agents.
The investigators hypothesize that a single MR-based examination in the preoperative evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate as the current multiple imaging work-up protocol.
详细描述
An accurate preoperative assessment of the renal donor is essential to minimize the risks for the donor & optimize the results for the recipient.
The current preoperative assessment includes Ultrasound, CT & Renal Scintigraphy. The latter two tests subjects the patient to the risk of a high radiation dose. Moreover, the use of iodinated contrast media during CT angiography may increase the risk of renal & systemic toxicity.
MRI can be a "one-stop shop" modality for preoperative assessment of living kidney donors. MRI also eliminates radiation exposure and the injection of potentially nephrotoxic iodinated contrast material.
The purpose of this study is to test the feasibility and evaluate the accuracy of a single MR-based examination, allowing for the comprehensive assessment of renal anatomy, function and vascular status in potential live kidney donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Potential renal donors with no known renal disease (initial medical screening performed and scheduled for further imaging evaluation as renal donor);
- •Age 18-65 years;
- •No medications (birth control pills and vitamins are acceptable).
排除标准
- •Pregnancy;
- •Age <18 years or >65 years;
- •MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.
结局指标
主要结局
Accuracy of MRI exam in kidney donors
时间窗: 2 years
To evaluate the accuracy of comprehensive Renal Magnetic Resonance Imaging (MRI) examination compared to CT angiography and Renal scintigraphy for the assessment of renal vascular anatomy and function in potential kidney donors.
次要结局
- cost analysis(2 years)