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OpenTrials
Enrolling by Invitation

NCT Number: NCT05764642

A Study of Renal Microvessel Imaging for Chronic Kidney Disease

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.

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Key information

Conditions

Healthy Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Definity

Drug

Ultrasound contrast agent administered intravenously

Other names: Perflutren Lipid Microsphere

Super-resolution ultrasound imaging

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.

Other names: SRUI

Primary outcomes

  1. Renal cortex microvessel density

    Time frame: Baseline

    Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage

  2. Renal cortex microvessel diameter

    Time frame: Baseline

    Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)

  3. Renal blood flow velocity

    Time frame: Baseline

    Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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