A Study of Renal Microvessel Imaging for Chronic Kidney Disease

NCT ID: NCT05764642

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Chronic Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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 Definity ultrasound contrast agent.

Group Type EXPERIMENTAL

Definity

Intervention Type DRUG

Ultrasound contrast agent administered intravenously

Super-resolution ultrasound imaging

Intervention Type DIAGNOSTIC_TEST

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.

Healthy Control Group

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

Group Type ACTIVE_COMPARATOR

Definity

Intervention Type DRUG

Ultrasound contrast agent administered intravenously

Super-resolution ultrasound imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Definity

Ultrasound contrast agent administered intravenously

Intervention Type DRUG

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Perflutren Lipid Microsphere SRUI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Shigao Chen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shigao Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK129205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-006499

Identifier Type: -

Identifier Source: org_study_id

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