Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy

This study is currently recruiting participants.
Verified October 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781208
First received: January 29, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

A new technique called Ultrasound-based Acoustic Radiation Force Impulse (ARFI)imaging is performed using standard approved ultrasound machines and transducers but the sound waves or impulses are produced in a different pattern. We are going to evaluate the usefulness of this new technique in diagnosing different liver conditions.


Condition Intervention
Liver Fibrosis
Liver Inflammation
Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Acoustic Radiation Force Impulse Imaging [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To confirm that the sound waves and or impulses produced by this new ultrasound-based imaging effectively aids in the diagnosis of different liver conditions such as fibrosis and inflammation and/or rejection.


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound-based Acoustic Radiation Force Impulse (ARFI)
Research scans using the ultrasound-based acoustic radiation force impulse imaging technique will be completed. This research imaging will take approximately 5 to 10 minutes to complete.
Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Research scan using an ultrasound-based acoustic radiation force impulse will be used to image the liver. This is non-invasive and will take approximately 5 to 10 minutes to complete.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or younger
  • Scheduled to have a needle biopsy of the liver at

    1. C.S. Mott Children's Hospital or
    2. Dept. of Radiology at the Univ. of Michigan Hospital
  • Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

Exclusion Criteria:

  • None to list
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781208

Contacts
Contact: Jonathan Dillman, M.D. 734-232-9247
Contact: James Pool, Jr., CCRC 734-615-7391 jampool@umich.edu

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: NCT01781208     History of Changes
Other Study ID Numbers: HUM00063736
Study First Received: January 29, 2013
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Inflammation
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014