A Study of Renal Microvessel Imaging for Chronic Kidney Disease
Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
2 other identifiers
interventional
186
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 healthy
Started Aug 2023
Longer than P75 for phase_2 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
August 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 5, 2025
September 1, 2025
4.6 years
February 28, 2023
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Renal cortex microvessel density
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Baseline
Renal cortex microvessel diameter
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Baseline
Renal blood flow velocity
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Baseline
Study Arms (2)
Chronic Kidney Disease Group
EXPERIMENTALSubjects 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.
Healthy Control Group
ACTIVE COMPARATORHealthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Interventions
Ultrasound contrast agent administered intravenously
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.
Eligibility Criteria
You may qualify if:
- \- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shigao Chen, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 10, 2023
Study Start
August 9, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share