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

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:
NCT01781208
First received: January 29, 2013
Last updated: June 4, 2014
Last verified: June 2014
  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
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: 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: June 4, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014