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Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound

Primary Purpose

Chronic Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acoustic Radiation Force Imaging
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease

Eligibility Criteria

1 Day - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Less than 25 years old with chronic liver disease

Exclusion Criteria:

  • Subjects without clinically ordered MRE
  • Subjects who cannot cooperate with performance of the short ARFI exam

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study cohort

    Arm Description

    Acoustic Radiation Force Imaging

    Outcomes

    Primary Outcome Measures

    Agreement in Measured Liver Stiffness Between ARFI and MRE
    The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis

    Secondary Outcome Measures

    Full Information

    First Posted
    January 4, 2016
    Last Updated
    June 13, 2017
    Sponsor
    Children's Hospital Medical Center, Cincinnati
    Collaborators
    Siemens Medical Solutions
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02652221
    Brief Title
    Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
    Official Title
    Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital Medical Center, Cincinnati
    Collaborators
    Siemens Medical Solutions

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.
    Detailed Description
    ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Liver Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study cohort
    Arm Type
    Experimental
    Arm Description
    Acoustic Radiation Force Imaging
    Intervention Type
    Device
    Intervention Name(s)
    Acoustic Radiation Force Imaging
    Other Intervention Name(s)
    ARFI
    Intervention Description
    ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
    Primary Outcome Measure Information:
    Title
    Agreement in Measured Liver Stiffness Between ARFI and MRE
    Description
    The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis
    Time Frame
    Within 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Less than 25 years old with chronic liver disease Exclusion Criteria: Subjects without clinically ordered MRE Subjects who cannot cooperate with performance of the short ARFI exam
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Trout, M.D.
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound

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