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Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Primary Purpose

Fatty Liver, Steatosis of Liver

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI of donor liver prior to transplant
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fatty Liver focused on measuring transplantation, liver

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are scheduled to orthoptic liver transplant

Exclusion Criteria:

  • Patient's who do not agree to sign consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI of donor liver

    Arm Description

    MRI evaluation of graft steatosis in donor liver prior to transplantation

    Outcomes

    Primary Outcome Measures

    Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
    Amount of fat measured in the donor liver prior to transplant surgery using MRI scan

    Secondary Outcome Measures

    Comparison of steatosis percentages provided by biopsy to MRI results
    Length of hospitalization of transplant recipient
    Mortality of liver transplant recipient at 1 year post transplantation

    Full Information

    First Posted
    August 4, 2016
    Last Updated
    January 31, 2018
    Sponsor
    Vanderbilt University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02873507
    Brief Title
    Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
    Official Title
    Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.
    Detailed Description
    The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatty Liver, Steatosis of Liver
    Keywords
    transplantation, liver

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    MRI of donor liver
    Arm Type
    Experimental
    Arm Description
    MRI evaluation of graft steatosis in donor liver prior to transplantation
    Intervention Type
    Other
    Intervention Name(s)
    MRI of donor liver prior to transplant
    Intervention Description
    MRI of the on ice donor liver within the transport cooler on its way to the operating room
    Primary Outcome Measure Information:
    Title
    Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
    Description
    Amount of fat measured in the donor liver prior to transplant surgery using MRI scan
    Time Frame
    Measured immediately prior to liver transplant
    Secondary Outcome Measure Information:
    Title
    Comparison of steatosis percentages provided by biopsy to MRI results
    Time Frame
    Baseline
    Title
    Length of hospitalization of transplant recipient
    Time Frame
    Days to hospital discharge, approximately 2 weeks
    Title
    Mortality of liver transplant recipient at 1 year post transplantation
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who are scheduled to orthoptic liver transplant Exclusion Criteria: Patient's who do not agree to sign consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bret D Alvis, M.D.
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

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