Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 186
- 试验地点
- 4
- 主要终点
- Renal cortex microvessel diameter
研究概览
简要总结
The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
排除标准
- •Subjects lacking capacity to consent.
- •Vulnerable subjects such as prisoners; pregnant women; nursing mother.
- •Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
- •Patients with high-risk cardiac diseases.
研究组 & 干预措施
Chronic Kidney Disease Group
Subjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
干预措施: Definity (Drug)
Healthy Control Group
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
干预措施: Definity (Drug)
Chronic Kidney Disease Group
Subjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
干预措施: Super-resolution ultrasound imaging (Diagnostic Test)
Healthy Control Group
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
干预措施: Super-resolution ultrasound imaging (Diagnostic Test)
结局指标
主要结局
Renal cortex microvessel diameter
时间窗: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity
时间窗: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Renal cortex microvessel density
时间窗: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
次要结局
未报告次要终点