Utilization of MAsS in Patients Undergoing LT for HCC

NCT05184283 | Terminated

• 1 other identifier: AAAT7360
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Hepatocellular Carcinoma; Liver Diseases; Liver Cancer; Cirrhosis, Liver; Hepatitis C

Keywords

NAFLD; Hepatocellular Carcinoma; Liver Diseases; Liver Cancer; Cirrhosis, Liver; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Change in mean muscle volume

  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

  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 Outcomes (6)

• Survival Rate

  Day 90, Day 180, 1 year

• Number of participants that dropped out of study

  1 year

• MRI-proton density fat fraction (MRI-PDFF)

  Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)

• Visceral adipose tissue volume

  1 year

• Abdominal subcutaneous adipose tissue volume

  1 year

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Amra Medical AB: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (14)

• Doycheva I, Issa D, Watt KD, Lopez R, Rifai G, Alkhouri N. Nonalcoholic Steatohepatitis is the Most Rapidly Increasing Indication for Liver Transplantation in Young Adults in the United States. J Clin Gastroenterol. 2018 Apr;52(4):339-346. doi: 10.1097/MCG.0000000000000925.

  PMID: 28961576 BACKGROUND

• Wong RJ, Aguilar M, Cheung R, Perumpail RB, Harrison SA, Younossi ZM, Ahmed A. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States. Gastroenterology. 2015 Mar;148(3):547-55. doi: 10.1053/j.gastro.2014.11.039. Epub 2014 Nov 25.

  PMID: 25461851 BACKGROUND

• Cholankeril G, Wong RJ, Hu M, Perumpail RB, Yoo ER, Puri P, Younossi ZM, Harrison SA, Ahmed A. Liver Transplantation for Nonalcoholic Steatohepatitis in the US: Temporal Trends and Outcomes. Dig Dis Sci. 2017 Oct;62(10):2915-2922. doi: 10.1007/s10620-017-4684-x. Epub 2017 Jul 25.

  PMID: 28744836 BACKGROUND

• Parikh ND, Marrero WJ, Wang J, Steuer J, Tapper EB, Konerman M, Singal AG, Hutton DW, Byon E, Lavieri MS. Projected increase in obesity and non-alcoholic-steatohepatitis-related liver transplantation waitlist additions in the United States. Hepatology. 2019 Aug;70(2):487-495. doi: 10.1002/hep.29473. Epub 2018 May 14.

  PMID: 28833326 BACKGROUND

• Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133. doi: 10.1002/hep.29466. Epub 2017 Dec 1.

  PMID: 28802062 BACKGROUND

• Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22.

  PMID: 29785727 BACKGROUND

• Linge J, Ekstedt M, Dahlqvist Leinhard O. Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD. JHEP Rep. 2020 Oct 28;3(1):100197. doi: 10.1016/j.jhepr.2020.100197. eCollection 2021 Feb.

  PMID: 33598647 BACKGROUND

• Linge J, Heymsfield SB, Dahlqvist Leinhard O. On the Definition of Sarcopenia in the Presence of Aging and Obesity-Initial Results from UK Biobank. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):1309-1316. doi: 10.1093/gerona/glz229.

  PMID: 31642894 BACKGROUND

• Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2.

  PMID: 26768490 BACKGROUND

• West J, Romu T, Thorell S, Lindblom H, Berin E, Holm AS, Astrand LL, Karlsson A, Borga M, Hammar M, Leinhard OD. Precision of MRI-based body composition measurements of postmenopausal women. PLoS One. 2018 Feb 7;13(2):e0192495. doi: 10.1371/journal.pone.0192495. eCollection 2018.

  PMID: 29415060 BACKGROUND

• West J, Dahlqvist Leinhard O, Romu T, Collins R, Garratt S, Bell JD, Borga M, Thomas L. Feasibility of MR-Based Body Composition Analysis in Large Scale Population Studies. PLoS One. 2016 Sep 23;11(9):e0163332. doi: 10.1371/journal.pone.0163332. eCollection 2016.

  PMID: 27662190 BACKGROUND

• Karlsson A, Rosander J, Romu T, Tallberg J, Gronqvist A, Borga M, Dahlqvist Leinhard O. Automatic and quantitative assessment of regional muscle volume by multi-atlas segmentation using whole-body water-fat MRI. J Magn Reson Imaging. 2015 Jun;41(6):1558-69. doi: 10.1002/jmri.24726. Epub 2014 Aug 11.

  PMID: 25111561 BACKGROUND

• Ajmera VH, Cachay E, Ramers C, Vodkin I, Bassirian S, Singh S, Mangla N, Bettencourt R, Aldous JL, Park D, Lee D, Blanchard J, Mamidipalli A, Boehringer A, Aslam S, Leinhard OD, Richards L, Sirlin C, Loomba R. MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial). Hepatology. 2019 Nov;70(5):1531-1545. doi: 10.1002/hep.30674. Epub 2019 Jun 18.

  PMID: 31013363 BACKGROUND

• Middleton MS, Haufe W, Hooker J, Borga M, Dahlqvist Leinhard O, Romu T, Tunon P, Hamilton G, Wolfson T, Gamst A, Loomba R, Sirlin CB. Quantifying Abdominal Adipose Tissue and Thigh Muscle Volume and Hepatic Proton Density Fat Fraction: Repeatability and Accuracy of an MR Imaging-based, Semiautomated Analysis Method. Radiology. 2017 May;283(2):438-449. doi: 10.1148/radiol.2017160606. Epub 2017 Mar 9.

  PMID: 28278002 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Carcinoma, Hepatocellular; Liver Diseases; Liver Neoplasms; Liver Cirrhosis; Hepatitis C

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• Julia Wattacheril, MD

  Columbia University Irving Medical Center/ New York Presbyterian hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: June 16, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)