Utilization of MAsS in Patients Undergoing LT for HCC

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05184283

Collaborator

Amra Medical AB (Industry)

100

Enrollment

Location

38.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD Hepatocellular Carcinoma Liver Diseases Liver Cancer Cirrhosis, Liver Hepatitis C

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Change in mean muscle volume [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.
Change in mean muscle fat [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

Secondary Outcome Measures

Survival Rate [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
Number of participants that dropped out of study [1 year]
This is to measure how many participants did not complete the study for any cause
MRI-proton density fat fraction (MRI-PDFF) [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
Visceral adipose tissue volume [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
Abdominal subcutaneous adipose tissue volume [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
Delta HOMA-IR [1 year]
Delta homeostasis model assessment of insulin resistance (HOMA-IR) will be assessed using plasma glucose, insulin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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