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Ultrasound Based Acoustic Radiation Force Impulse Imaging

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ClinicalTrials.gov Identifier: NCT01781208
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan

Study Description
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Brief Summary:
ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Liver Inflammation Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781208


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jonathan Dillman, M.D. University of Michigan Hospital
More Information
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Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01781208    
Other Study ID Numbers: HUM00063736
First Posted: January 31, 2013    Key Record Dates
Results First Posted: October 21, 2016
Last Update Posted: October 21, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatitis
Inflammation
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases