(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients

Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux

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).

Study Overview

• Status: Withdrawn
• Conditions: Kidney Damage; Urine Reflux
• Intervention / Treatment: Procedure: ARFI SVI Ultrasound Imaging

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age and younger
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARFI SVI ultrasound imaging; Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging	Procedure: ARFI SVI Ultrasound Imaging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Jonathan Dillman, MD, University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: HUM00063972