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A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Status
Enrolling by invitation
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05764642
Enrollment
186
Registered
2023-03-10
Start date
2023-08-09
Completion date
2028-04-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Healthy

Brief 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.

Interventions

DRUGDefinity

Ultrasound contrast agent administered intravenously

DIAGNOSTIC_TESTSuper-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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Renal cortex microvessel densityBaselineSuper-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Renal cortex microvessel diameterBaselineSuper-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocityBaselineSuper-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShigao Chen, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026