Hydronephrosis ARFI Study

This study has been completed.
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
First received: January 30, 2013
Last updated: May 29, 2015
Last verified: May 2015

Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard.

Condition Intervention
Procedure: AFRI-SVI Ultrasound

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • ARFI-SVI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.

Enrollment: 41
Study Start Date: November 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARFI-SVI Ultrasound
Ultrasound scan using acoustic radiation force impulse-shear wave velocity imaging in the characterization of pediatric hydronephrosis. This is a non-invasive scan that uses sound waves to create the images.
Procedure: AFRI-SVI Ultrasound
This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI)a new ultrasound technology in which unique sound waves create the images/pictures of the kidney beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.


Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 years of age or younger
  2. You are scheduled for diuretic scintigraphy (DRS)testing -

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01781845

United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Jonathan Dillman, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01781845     History of Changes
Other Study ID Numbers: HUM00064524
Study First Received: January 30, 2013
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 02, 2015