Validation of Contrast Enhanced Ultrasound (CEUS) for the Assessment of Renal Perfusion Using Renal Magnetic Resonance Imaging (MRI) in Chronic Kidney Disease (CKD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
研究概览
简要总结
Blood flow to the kidneys is important in the development of kidney diseases. Currently we do not have ways of measuring and monitoring kidney blood flow for patients in real-time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
Kidney blood flow can be reliably measured using a specialised type of MRI scan, but this is expensive and difficult to do in people who are unwell. Contrast-enhanced ultrasound (CEUS) is a new technique, which uses a contrast containing microbubbles to measure blood flow. The benefits of this method are that it is relatively inexpensive, the contrast agents are not kidney-damaging and it can be done at the bedside.
We want to compare contrast enhanced ultrasound against the current best-measure of kidney blood flow, to see if it is giving accurate information about kidney blood flow. We will do this by doing both MRI and contrast enhanced ultrasound scans in people with chronic kidney disease and comparing the results.
详细描述
Renal perfusion, the delivery of oxygenated blood to kidney tissues, is relevant to a number of acute and chronic kidney diseases. Despite this, we do not have methods in current clinical practice to measure renal perfusion and monitor the response to supportive treatments in real time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
The current non-invasive gold standard technique for renal perfusion measurement is arterial-spin labelling magnetic resonance imaging (ASL-MRI), which has been validated against other measures of perfusion, including contrast agent-based methods. However, MRI has limitations including high cost, and logistical barriers. Therefore, validation of a bed-side measurement tool for renal perfusion would be of significant clinical importance.
This proposal aims to validate CEUS renal cortical perfusion measurement by comparison with quantifiable ASL-MRI parameters of renal microvascular perfusion in individuals with CKD.
TRIAL REGIMEN
All interventions outlined below are for the purposes of research, not usual care.
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
- 否
入选标准
- •CKD 3b or CKD4
- •Ability to give informed consent
排除标准
- •Autosomal dominant polycystic kidney disease
- •Solid organ transplant
- •Pregnant women
- •Known allergy to Sonovue
- •Contraindications to MRI
结局指标
主要结局
Correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
时间窗: MRI scan and contrast enhanced ultrasound scan to be performed within 7 days of each other.
The primary outcome will be the correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow. As CEUS and ASL-MRI generate different units of measurement, correlations (rather than Bland-Altman analyses) will be used. We will define an ideal result as correlation coefficient r≥0.65, and adequate correlation coefficient r≥0.4.
次要结局
- Repeatability of the CEUS measurements(1 scan)
- Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA(MRI scan and CEUS done within 7 days of each other)
- Correlation between global perfusion from PC-MRI corrected flow measures and CEUS(MRI scan and CEUS done within 7 days of each other)