Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

January 31, 2018 updated by: Bret Alvis, Vanderbilt University Medical Center

Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are scheduled to orthoptic liver transplant

Exclusion Criteria:

  • Patient's who do not agree to sign consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI of donor liver
MRI evaluation of graft steatosis in donor liver prior to transplantation
Other: MRI of donor liver prior to transplant
MRI of the on ice donor liver within the transport cooler on its way to the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
Time Frame: Measured immediately prior to liver transplant
Amount of fat measured in the donor liver prior to transplant surgery using MRI scan
Measured immediately prior to liver transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of steatosis percentages provided by biopsy to MRI results
Time Frame: Baseline
Baseline
Length of hospitalization of transplant recipient
Time Frame: Days to hospital discharge, approximately 2 weeks
Days to hospital discharge, approximately 2 weeks
Mortality of liver transplant recipient at 1 year post transplantation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Bret D Alvis, M.D., Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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