Back to results(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
Primary Purpose
Urine Reflux, Kidney Damage
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARFI SVI Ultrasound Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Urine Reflux
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and younger
- Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -
Exclusion Criteria:
None to list
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARFI SVI ultrasound imaging
Arm Description
Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging
Outcomes
Primary Outcome Measures
Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI)
To determine if this new ultrasound based imaging will effectively measure shear wave velocity in kidneys affected by urine reflux and be useful in determining the extent of kidney damage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01781819
Brief Title
(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
Official Title
Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving institution
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Urine reflux (urine backing up into the kidneys) is common in the pediatric population and may be complicated by renal abnormalities, such as infection and scarring. Currently, urine reflux is detected using either voiding cystourethrogram or other procedures. A new technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity imaging SVI) is performed using standard approved ultrasound machines and transducers bu the sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into the kidneys).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urine Reflux, Kidney Damage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARFI SVI ultrasound imaging
Arm Type
Experimental
Arm Description
Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging
Intervention Type
Procedure
Intervention Name(s)
ARFI SVI Ultrasound Imaging
Intervention Description
Following a clinical renal ultrasound scan, the research scan using the ultrasound based acoustic radiation force impulse, or shear wave velocity imaging will be performed using standard approved ultrasound machines and transducers. This imaging will take approximately 5 to 10 minutes to complete.
Primary Outcome Measure Information:
Title
Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI)
Description
To determine if this new ultrasound based imaging will effectively measure shear wave velocity in kidneys affected by urine reflux and be useful in determining the extent of kidney damage
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and younger
Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -
Exclusion Criteria:
None to list
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Dillman, MD
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
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