Non-contrast Enhanced MR Imaging of the Kidney in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- T2*
研究概览
简要总结
Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.
Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA), phase-contrast MRI), which could be used in combination with structural MRI in a single acquisition session, have been identified to investigate in more detail renal function and structure, opening the possibility to estimate local renal diffusion and blood perfusion, beyond providing high-resolution anatomical accuracy.
Preliminary to the identification of novel imaging biomarkers of renal disease progression, perfusion and diffusion MR sequences need to be optimized for the renal compartment. Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and diffusion changes in pathological kidneys as compared to normal and physiological condition.
The objective of this study is to provide normal control NCE-MRI sequences to be used as reference for the investigation of perfusion and diffusion changes in the kidney of patients affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal dominant polycystic kidney disease).
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
- 20 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 20 and ≤59 years ;
- •Healthy volunteers;
- •Written informed consent.
排除标准
- •Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment;
- •Pregnancy (due to safety reasons).
研究组 & 干预措施
Whole Group
干预措施: Non contrast-enhanced magnetic resonance imaging (Device)
结局指标
主要结局
T2*
时间窗: At baseline.
Renal blood oxygenation parameter assessed by Blood Oxygenation Level Dependent (BOLD) MRI, characterising normal physiology.
Renal artery flow.
时间窗: At baseline.
Renal perfusion parameter assessed by Phase-Contrast (PC) MRI, characterising normal physiology.
Apparent Diffusion Coefficient (ADC)
时间窗: At baseline.
Renal perfusion and diffusion parameter assessed by Diffusion Weighted Imaging (DWI) MRI, characterising normal physiology.
次要结局
未报告次要终点
