Super-resolution Ultrasound Imaging for Chronic Kidney Disease

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

186 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Lumason for chronic kidney disease?

Research shows that microbubbles based on sulfur hexafluoride, like those in Lumason, have been developed to enhance ultrasound imaging, which can improve the visibility of organs like the liver and kidney. This suggests that Lumason may help in better imaging of the kidneys in chronic kidney disease. ^{1 2 3 4 5}

Is Lumason safe for use in humans?

Lumason, an ultrasound contrast agent, is generally safe for use in humans, including special populations and critically ill patients. Serious allergic reactions are rare, but healthcare providers should be prepared for them. Post-marketing data over 20 years show very low rates of adverse events. ^{6 7 8 9 10}

What makes Lumason unique for treating chronic kidney disease?

Lumason is unique because it is a microbubble-based ultrasound contrast agent that enhances imaging of the kidney's microvasculature, allowing for noninvasive and detailed visualization of blood flow and potential abnormalities, which is not typically possible with standard treatments. ^{1 4 5 11 12}

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.

Research Team

Shigao Chen, PhD

Principal Investigator

Mayo Clinic

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Renal ultrafiltration changes induced by focused US. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving ultrasound reflectivity and stability of echogenic liposomal dispersions for use as targeted ultrasound contrast agents. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Grey scale enhancement of rabbit liver and kidney by intravenous injection of a new lipid-coated ultrasound contrast agent. [2019]

5. England pubmed.ncbi.nlm.nih.gov

In vitro characterization of liposomes and Optison by acoustic scattering at 3.5 MHz. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Anaphylaxis to Lumason Contrast Agent in Echocardiography after Immune Sensitization: A Case Report and Literature Review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Lumason® (SonoVue®) in special populations and critically ill patients. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Renal cortical perfusion in rabbits: visualization with color amplitude imaging and an experimental microbubble-based US contrast agent. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Current Development and Applications of Super-Resolution Ultrasound Imaging. [2021]