Utilization of MAsS in Patients Undergoing LT for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05184283
• Other study ID #: AAAT7360
• Status: Terminated
• Start date: June 16, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis, Liver
• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Cirrhosis
• Liver Diseases
• Liver Neoplasms
• NAFLD

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Amra Medical AB

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

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