Super-resolution Ultrasound Imaging for Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen byShigao Chen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for healthy volunteers or patients with Chronic Kidney Disease who need a kidney biopsy. It's not open to those unable to consent, prisoners, pregnant or nursing women, people allergic to ultrasound contrast agents, or patients with serious heart conditions.

Inclusion Criteria

I am healthy or have CKD and need a kidney biopsy.

Exclusion Criteria

I have a serious heart condition.

You have had severe allergic reactions to ultrasound contrast agents in the past.

I am unable to give consent by myself due to my condition.

+1 more

Participant Groups

The study tests how well Definity (an FDA-approved contrast agent for the heart, liver, and urinary tract) works in ultrasound imaging of kidneys in individuals with Chronic Kidney Disease compared to healthy subjects.

2Treatment groups

Experimental Treatment

Active Control

Group I: Chronic Kidney Disease GroupExperimental Treatment2 Interventions

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.

Group II: Healthy Control GroupActive Control2 Interventions

Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.

Lumason is already approved in United States for the following indications:

🇺🇸 Approved in United States as Lumason for:

Echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
Ultrasonography of the liver to characterize focal liver lesions in adult and pediatric patients
Ultrasonography of the urinary tract for the evaluation of suspected or unknown vesicoureteral reflux in pediatric patients