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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Renal blood flow velocity

Renal cortex microvessel density

Renal cortex microvessel diameter

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

~520

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,000 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,897 Total Patients Enrolled

Shigao Chen, PhDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

279 Total Patients Enrolled

Media Library

Lumason (Ultrasound Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05764642 — Phase 2

Healthy Subjects Research Study Groups: Chronic Kidney Disease Group, Healthy Control Group

Healthy Subjects Clinical Trial 2023: Lumason Highlights & Side Effects. Trial Name: NCT05764642 — Phase 2

Lumason (Ultrasound Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764642 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do individuals with Chronic Kidney Disease Group experience?

"The safety of the Chronic Kidney Disease Group was judged to be a 2. This is attributed to it being in Phase 2 of the trial, where there has been some documented evidence for its security but none for efficacy."

Answered by AI

Is enrollment for this experiment open to the public?

"According to data hosted on clinicaltrials.gov, this trial is no longer recruiting patients; the listing was first posted April 1st 2023 and last updated February 28th of that year. Fortunately, there are a plethora of other studies actively enrolling participants currently available for consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Shigao Chen 2023. "A Study of Renal Microvessel Imaging for Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764642.

All > Chronic Kidney Disease