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Magnetic Resonance Elastography in Infants (MREI)

Primary Purpose

Liver Disease

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI with MRE
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 Liver Disease focused on measuring liver, mre, mri, neonatal, mr touch

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants < 6 months of age
  • Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age)
  • Parental/LAR permission obtained

Exclusion Criteria:

  • Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
  • Severe coagulopathy (INR > 3 or platelets <50,000)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI with MRE

    Arm Description

    Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

    Outcomes

    Primary Outcome Measures

    Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
    To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2014
    Last Updated
    August 17, 2020
    Sponsor
    Children's Hospital Medical Center, Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02201472
    Brief Title
    Magnetic Resonance Elastography in Infants
    Acronym
    MREI
    Official Title
    Magnetic Resonance Elastography in Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Change of research focus
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    MRI & MRE in infants
    Detailed Description
    The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Disease
    Keywords
    liver, mre, mri, neonatal, mr touch

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Magnetic resonance elastography on infants with suspected liver disease
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI with MRE
    Arm Type
    Experimental
    Arm Description
    Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
    Intervention Type
    Device
    Intervention Name(s)
    MRI with MRE
    Intervention Description
    Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
    Primary Outcome Measure Information:
    Title
    Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
    Description
    To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants < 6 months of age Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age) Parental/LAR permission obtained Exclusion Criteria: Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology Severe coagulopathy (INR > 3 or platelets <50,000)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephanie Merhar, MD
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Magnetic Resonance Elastography in Infants

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