A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05764642
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Chronic Kidney Diseases
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Definity — DRUG
    Ultrasound contrast agent administered intravenously
  • 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.

Study Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Sep 2025
Primary completion
Apr 1, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
186 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Renal cortex microvessel density [ Time Frame: Baseline ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224-
Mayo Clinic MinnesotaRochesterMinnesota55905-

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic Florida· Jacksonville, FLMayo Clinic Minnesota· Rochester, MN

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