Back to resultsA Study of Renal Microvessel Imaging for Chronic Kidney Disease
Primary Purpose
Healthy, Chronic Kidney Diseases
Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Definity
Super-resolution ultrasound imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chronic Kidney Disease Group
Healthy Control Group
Arm Description
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.
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Outcomes
Primary Outcome Measures
Renal cortex microvessel density
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Renal cortex microvessel diameter
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Secondary Outcome Measures
Full Information
NCT ID
NCT05764642
First Posted
February 28, 2023
Last Updated
September 11, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05764642
Brief Title
A Study of Renal Microvessel Imaging for Chronic Kidney Disease
Official Title
Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic Kidney Disease Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control Group
Arm Type
Active Comparator
Arm Description
Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Intervention Type
Drug
Intervention Name(s)
Definity
Other Intervention Name(s)
Perflutren Lipid Microsphere
Intervention Description
Ultrasound contrast agent administered intravenously
Intervention Type
Diagnostic Test
Intervention Name(s)
Super-resolution ultrasound imaging
Other Intervention Name(s)
SRUI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Renal cortex microvessel density
Description
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Time Frame
Baseline
Title
Renal cortex microvessel diameter
Description
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Time Frame
Baseline
Title
Renal blood flow velocity
Description
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigao Chen, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Renal Microvessel Imaging for Chronic Kidney Disease
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