A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05764642

Collaborator

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

186

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Lumason 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Chronic Kidney Diseases	Drug: Lumason Diagnostic Test: Super-resolution ultrasound imaging	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

186 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2028

Anticipated Study Completion Date :

Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chronic Kidney Disease Group Subjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Lumason ultrasound contrast agent.	Drug: Lumason Ultrasound contrast agent administered intravenously Diagnostic Test: Super-resolution ultrasound imaging Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging. Other Names: SRUI
Active Comparator: Healthy Control Group Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Lumason ultrasound contrast agent.	Drug: Lumason Ultrasound contrast agent administered intravenously Diagnostic Test: Super-resolution ultrasound imaging Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging. Other Names: SRUI

Arm

Intervention/Treatment

Experimental: Chronic Kidney Disease Group

Subjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Lumason ultrasound contrast agent.

Drug: Lumason

Ultrasound contrast agent administered intravenously

Diagnostic Test: Super-resolution ultrasound imaging

Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging.

Other Names:

SRUI

Active Comparator: Healthy Control Group

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

Drug: Lumason

Ultrasound contrast agent administered intravenously

Diagnostic Test: Super-resolution ultrasound imaging

Other Names:

SRUI

Outcome Measures

Primary Outcome Measures

Renal cortex microvessel density [Baseline]
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Renal cortex microvessel diameter [Baseline]
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity [Baseline]
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Subjects lacking capacity to consent.
Vulnerable subjects such as prisoners; pregnant women; nursing mother.
Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
Patients with high-risk cardiac diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

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

Investigators

Principal Investigator: Shigao Chen, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Shiago Chen, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05764642

Other Study ID Numbers:

22-006499
R01DK129205

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 10, 2023