Utilization of MAsS in Patients Undergoing LT for HCC

December 1, 2023 updated by: Julia Wattacheril, Columbia University

Longitudinal Assessment of Muscle Health in Patients Undergoing Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

The aim of this study is to determine the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma.

Study Overview

Status

Terminated

Conditions

Detailed Description

The combination of hepatocellular carcinoma and chronic liver disease represents a dual impact on overall metabolism. The major risk factors for chronic liver disease related-hepatocellular carcinoma (HCC) include nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury.

Of particular interest is how the changing landscape of liver disease impacts the care of patients in the peritransplant period. Numerous recent studies have reported that nonalcoholic steatohepatitis (NASH)-related cirrhosis is the most rapidly growing indication for liver transplantation (LT) in the Western world. NAFLD related HCC is already a leading indication in women. The impact of NAFLD on public health and mortality is substantial: incident decompensated cirrhosis due to NAFLD is predicted to increase by 168%, from 39,230 cases annually in 2015 to 105,430 cases in 2030. The corresponding burden of NAFLD cirrhosis on liver transplantation (LT) is expected to increase by 59%. Finally, 3% per year of cirrhotic patients because of NAFLD, develop HCC and noncirrhotic NAFLD-HCC continues to be an area of investigation.

Since NAFLD is becoming one of the most frequent causes of cirrhosis, HCC, and liver transplantation worldwide, it is crucial to identify changes in the peritransplant period that are associated with adverse muscle health and unfavorable metabolic status in the context of all chronic liver diseases.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma at risk of nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury

Description

Inclusion Criteria:

  • Age between 18 and 75 years
  • Diagnosis of cirrhosis and HCC
  • Listed or in evaluation for liver transplantation

Exclusion Criteria:

  • History of prior solid organ transplantation
  • In evaluation or listed for any other solid organ transplant (other than liver transplant)
  • Contraindication to MR examination
  • Metastatic HCC

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

Cohorts and Interventions

Group / Cohort
Prospective Cohort
Chart review will be performed for patients who consent to inclusion in the study. Information from routine care will be reviewed and body composition assessment will be done by routine MRI with an additional 6-8 minute scan using AMRA® Profiler 4 Muscle Assessment Score (MAsS) by performing volumetric quantification of fat and water images acquired with 2-point Dixon magnetic resonance imaging (MRI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean muscle volume
Time Frame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
Muscle volume will be collected using body composition MR image acquisition that adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination.
Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
Change in mean muscle fat
Time Frame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
Muscle fat will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: Day 90, Day 180, 1 year
The percentage of people that are still alive at each time point post transplant compare to 89% average survival rate
Day 90, Day 180, 1 year
Number of participants that dropped out of study
Time Frame: 1 year
This is to measure how many participants did not complete the study for any cause
1 year
MRI-proton density fat fraction (MRI-PDFF)
Time Frame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
This is to measure/assess intrahepatic fat (IHF) using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
Visceral adipose tissue volume
Time Frame: 1 year
Visceral adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
1 year
Abdominal subcutaneous adipose tissue volume
Time Frame: 1 year
Abdominal subcutaneous adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
1 year
Delta HOMA-IR
Time Frame: 1 year
Delta homeostasis model assessment of insulin resistance (HOMA-IR) will be assessed using plasma glucose, insulin
1 year

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

Amra Medical AB

Investigators

  • Principal Investigator: Julia Wattacheril, MD, Columbia University Irving Medical Center/ New York Presbyterian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 16, 2022

Primary Completion (Actual)

November 29, 2023

Study Completion (Actual)

November 29, 2023

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT7360

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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