Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- degree of agreement
研究概览
简要总结
The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).
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
- 是
入选标准
- •Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment
- •Mandatory enrollment in a health security plan (French Social Security)
- •Subject having signed an informed consent
排除标准
- •Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy
- •Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney)
- •Subjets under a legal protection measure
结局指标
主要结局
degree of agreement
时间窗: through study completion (2 years)
Differential renal function (DRF) measured by each technique (CT and SPECT) Regions of interest will be drawn on each kidney and the aorta to obtain time-intensity curves and derive the Patlak plot; the Patlak model will then be used to determine the slope of each kidney and thus to calculate the differential renal function (percentage of each kidney in the total renal function). Degree of agreement will be assessed by calculating the intra-class correlation coefficient and its 95% confidence interval, and the Bland-Altman plot.
次要结局
- Radiation dose exposure for each technique(1 day)
- Agreement between post-processing methods for CT(through study completion (2 years))
- Intra- and inter-observer reproducibility of CT DRF measurement(through study completion (2 years))
- Automatic post-processing for Patlak-Ruthland method(through study completion (2 years))