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Ultrasound Based Acoustic Radiation Force Impulse Imaging

This study has been completed.
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan Identifier:
First received: January 29, 2013
Last updated: August 29, 2016
Last verified: August 2016
ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy

Resource links provided by NLM:

Further study details as provided by Jonathan R. Dillman M.D., University of Michigan:

Primary Outcome Measures:
  • ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score [ Time Frame: 10 minutes ]

    Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.

    Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.

Enrollment: 62
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: Ultrasound-based Acoustic Radiation Force Imaging
The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).
Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.

Detailed Description:
A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01781208

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

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan Identifier: NCT01781208     History of Changes
Other Study ID Numbers: HUM00063736
Study First Received: January 29, 2013
Results First Received: April 26, 2016
Last Updated: August 29, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases processed this record on May 25, 2017