A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Study 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.

Official Title
-----------------
Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Conditions
-----------------
Healthy, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Definity
* Diagnostic Test: Super-resolution ultrasound imaging


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic Kidney Disease Group<br>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. | Drug: Definity<br>* Ultrasound contrast agent administered intravenously<br>* Other names: Perflutren Lipid Microsphere;Diagnostic Test: Super-resolution ultrasound imaging<br>* Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging.<br>* Other names: SRUI;|
| Active Comparator: Healthy Control Group<br>Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent. | Drug: Definity<br>* Ultrasound contrast agent administered intravenously<br>* Other names: Perflutren Lipid Microsphere;Diagnostic Test: Super-resolution ultrasound imaging<br>* Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging.<br>* Other names: SRUI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal cortex microvessel density | Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage | Baseline | 
| Renal cortex microvessel diameter | Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm) | Baseline | 
| Renal blood flow velocity | Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec) | Baseline |