Super-resolution Ultrasound Imaging for Chronic Kidney Disease

Enrolling by invitation at 1 trial location

Overseen By Bobbie Ott

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Nursing, Cardiac diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special type of ultrasound imaging, called super-resolution ultrasound imaging, for individuals with Chronic Kidney Disease (CKD). The method uses an ultrasound contrast agent called Definity, already approved for other organs, to capture clear images of the kidneys. The study includes two groups: CKD patients requiring a kidney biopsy and healthy volunteers. Individuals with CKD undergoing a kidney biopsy or healthy individuals may participate. Those with a history of allergic reactions to ultrasound contrast agents or serious heart problems may not be eligible. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound imaging technique is safe for evaluating Chronic Kidney Disease?

Studies have shown that Lumason, the ultrasound contrast agent used in this trial, is generally well-tolerated. The FDA has already approved it for use in the heart, liver, and urinary tract. Research indicates that patients who received Lumason experienced very low rates of serious issues. Specifically, the death rate was only 0.03%, which was lower than in those who didn't receive any ultrasound contrast agent.

However, serious heart and lung reactions, including deaths, have occurred, although these are uncommon. This means that while the risk is low, it remains a consideration.

Overall, Lumason has a solid safety record but, like any medical treatment, it carries some risks. Participants should weigh these risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses Super-Resolution Ultrasound Imaging (SRUI) with the Definity ultrasound contrast agent to capture detailed images of kidney microvessels. Unlike standard imaging techniques, which might not clearly visualize tiny blood vessels in the kidneys, SRUI offers high-resolution images that could provide new insights into chronic kidney disease (CKD). This technique has the potential to improve diagnosis and understanding of CKD by offering a more precise view of kidney health.

What evidence suggests that this ultrasound imaging technique is effective for evaluating Chronic Kidney Disease?

Research has shown that Lumason, a special dye used in ultrasound scans, helps doctors see kidney problems more clearly. It distinguishes between solid tumors and complex cysts in the kidneys. Lumason enhances ultrasound images without much strain on the body. Although primarily used for the heart, liver, and urinary tract, it also shows promise for kidney imaging. In this trial, Lumason will obtain super-resolution ultrasound images for subjects with chronic kidney disease and healthy volunteers. These findings suggest Lumason could improve ultrasound imaging for chronic kidney disease detection. ^{1 6 7 8 9}

Who Is on the Research Team?

Shigao Chen, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent to evaluate renal microvessel characteristics

Baseline

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lumason

Trial Overview

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.

How Is the Trial Designed?

Group I: Chronic Kidney Disease Group Experimental Treatment 2 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 Group Active Control 2 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a large study of 463,434 contrast-enhanced ultrasound examinations, the use of sulfur hexafluoride microbubbles resulted in a very low adverse event (AE) frequency of only 0.034%, indicating a high safety profile for this contrast agent.

Among the reported AEs, only 4 were classified as serious, and the majority were non-serious, with most reactions occurring within 30 minutes of administration, confirming that sulfur hexafluoride microbubbles are safe for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. Shang, Y., Xie, X., Luo, Y., et al.[2023]

The experimental microbubble-based ultrasound contrast agent (Imagent US) significantly improved the visualization of renal perfusion in rabbits, with effective enhancement observed even at low doses (0.007 mL/kg).

The contrast agent allowed for clear differentiation between normally perfused and ischemic kidney areas, indicating its potential utility in identifying focal perfusion abnormalities in renal imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal cortical perfusion in rabbits: visualization with color amplitude imaging and an experimental microbubble-based US contrast agent. Taylor, GA., Ecklund, K., Dunning, PS.[2016]

Lumason® (SonoVue®) has been shown to be safe for use in special patient populations, including those with compromised cardiopulmonary conditions, with no significant adverse effects on cardiac or pulmonary function observed in studies involving patients with coronary artery disease, pulmonary hypertension, and chronic obstructive pulmonary disease.

A retrospective study of critically ill patients indicated that using Lumason® during echocardiography did not increase in-hospital mortality compared to echocardiography without the contrast agent, further supporting its safety profile in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Lumason® (SonoVue®) in special populations and critically ill patients. Filippone, A., Kirchin, MA., Monteith, J., et al.[2023]

The study developed new microbubbles using lipids and sulfur hexafluoride (SF6) that significantly enhance the echogenicity of thrombi, improving their visibility during ultrasound imaging.

These targeted microbubbles demonstrated high stability and maintained their characteristics for up to 8 hours, providing a longer diagnostic window compared to traditional nontargeted microbubbles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. Wang, B., Zang, WJ., Wang, M., et al.[2016]

The FDA has approved Lumason, a contrast agent for ultrasound, which is expected to enhance the characterization of focal liver lesions in both adults and children, promoting the use of contrast-enhanced ultrasound (CEUS) in clinical practice.

The paper outlines essential guidelines for establishing a CEUS program, including safety measures, indications, contraindications, and procedures for performing and interpreting CEUS exams, ensuring efficient and safe implementation in ultrasound departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Develop a Contrast-Enhanced Ultrasound Program. Barr, RG.[2018]

Lumason (sulfur hexafluoride microbubbles) has recently been FDA approved for characterizing focal liver lesions (FLL) in both pediatric and adult patients, which is expected to increase its use in routine clinical practice.

The literature indicates that contrast-enhanced ultrasound (CEUS) using Lumason is accurate for FLL characterization, with existing studies comparing its effectiveness to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMRI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound for focal liver lesions: how accurate is it? Barr, RG.[2019]

Citations

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LUMASON ultrasound enhancing agent delivers high-clarity imaging at a very low MI. 2,3 MI = Mechanical Index

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lumason.com/safety/

Safety

Patients who received LUMASON UEA had a mortality rate of only 0.03%—lower than in those who didn't receive a UEA.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2019/203684s005lbl.pdf

lumason - accessdata.fda.gov

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asecho.org

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LUMASON FORMULARY KIT

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including ...

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mayoclinic.org

mayoclinic.org/drugs-supplements/sulfur-hexafluoride-lipid-type-a-microspheres-injection-route-intravenous-route/description/drg-20405988

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Sulfur hexafluoride lipid type A microspheres is an ultrasound contrast agent. ... Safety and efficacy have been established. Geriatric.