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NCT05764642 Clinical Trial

A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Healthy Clinical Trial

Official title:
Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05764642
Other study ID # 22-006499
Secondary ID R01DK129205
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date August 9, 2023
Est. completion date April 2028

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 186
Est. completion date April 2028
Est. primary completion date April 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Definity
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.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Renal cortex microvessel density Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage Baseline
Primary Renal cortex microvessel diameter Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm) Baseline
Primary Renal blood flow velocity Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec) Baseline
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