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Ultrasound Contrast Agent

Super-resolution Ultrasound Imaging for Chronic Kidney Disease

Phase 2

Waitlist Available

Led By Shigao Chen, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.

Be older than 18 years old

Must not have

Patients with high-risk cardiac diseases.

Subjects lacking capacity to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if using Lumason ultrasound agent can help diagnose Chronic Kidney Disease. #CKD #Ultrasound #Lumason

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions similar to other uses of Definity such as shortness of breath, facial swelling, hives; however specific risks related to kidney imaging are being evaluated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Renal blood flow velocity

Renal cortex microvessel density

Renal cortex microvessel diameter

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Definity

2007

Completed Phase 4

~540

0 / 3Eligibility criteria met