Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
Overview
- Phase
- Phase 2
- Intervention
- Definity
- Conditions
- Healthy
- Sponsor
- Mayo Clinic
- Enrollment
- 186
- Locations
- 2
- Primary Endpoint
- Renal cortex microvessel diameter
- Status
- Enrolling by Invitation
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Shigao Chen
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •\- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Definity
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.
Intervention: Super-resolution ultrasound imaging
Healthy Control Group
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Intervention: Definity
Healthy Control Group
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Intervention: Super-resolution ultrasound imaging
Outcomes
Primary Outcomes
Renal cortex microvessel diameter
Time Frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity
Time Frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Renal cortex microvessel density
Time Frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage