Hydronephrosis ARFI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781845
First received: January 30, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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
Hydronephrosis
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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

None

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jonathan Dillman, M.D. 734-232-9247

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jonathan Dillman, M.D.    734-232-9247      
Contact: James Pool Jr., CCRC    734-615-7391    jampool@umich.edu   
Principal Investigator: Jonathan Dillman, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
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: June 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014