Utilization of MAsS in Patients Undergoing LT for HCC
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| ClinicalTrials.gov Identifier: NCT05184283 |
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Recruitment Status :
Recruiting
First Posted : January 11, 2022
Last Update Posted : July 5, 2022
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| Condition or disease |
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| NAFLD Hepatocellular Carcinoma Liver Diseases Liver Cancer Cirrhosis, Liver Hepatitis C |
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 |
| Estimated 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 : | June 16, 2022 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | September 2025 |
| Group/Cohort |
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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).
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- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- Delta HOMA-IR [ Time Frame: 1 year ]Delta homeostasis model assessment of insulin resistance (HOMA-IR) will be assessed using plasma glucose, insulin
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05184283
| Contact: Rachel Park | 212-305-3839 | hp2469@cumc.columbia.edu | |
| Contact: Theresa Lukose, PharmD | 212-305-7482 | tt2103@cumc.columbia.edu |
| United States, New York | |
| Columbia University Irving Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Rachel Park 212-305-3839 hp2469@cumc.columbia.edu | |
| Contact: Theresa Lukose, PharmD 212-305-7482 tt2103@cumc.columbia.edu | |
| Principal Investigator: Julia Wattacheril, MD | |
| Principal Investigator: | Julia Wattacheril, MD | Columbia University Irving Medical Center/ New York Presbyterian hospital |
| Responsible Party: | Julia Wattacheril, Associate Professor of Medicine, Columbia University |
| ClinicalTrials.gov Identifier: | NCT05184283 |
| Other Study ID Numbers: |
AAAT7360 |
| First Posted: | January 11, 2022 Key Record Dates |
| Last Update Posted: | July 5, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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NAFLD Hepatocellular Carcinoma Liver Diseases |
Liver Cancer Cirrhosis, Liver Hepatitis C |
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Hepatitis C Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Hepatitis Liver Cirrhosis Liver Diseases Fibrosis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Pathologic Processes |