Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03725631
• Other study ID #: 2016GR0302
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2018
• Source: Korea University Guro Hospital
• Contact: Jong Eun Yeon, MD, Ph.D.
• Phone: 82-2-2626-3010
• Email: jeyyeon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker

2. To develop non-invasive diagnosis marker for NASH and advanced fibrosis

Description:

As nonalcoholic fatty liver disease (NAFLD) is becoming a leading cause of chronic liver disease, non-invasive diagnosis of disease severity in NAFLD is urgently needed. In this study, the investigators compared hepatic fibrosis and steatosis using MR imaging and transient elastography (TE) and tried to find non-invasive diagnostic marker for NASH and advanced fibrosis.

This is a multicenter prospective study of patients with biopsy-proven NAFLD. The patients were underwent laboratory test, liver biopsy, MRI and TE within 6 months of enrollment. MRI examination included MR spectroscopy (MRS), and MR elastography (MRE). TE measured liver stiffness and controlled attenuation parameter (CAP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients >19 years age

• Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) or fatty liver on abdominal ultrasonography

• Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH): >40 years age, BMI >25, multiple features of the metabolic syndrome, presence of diabetes mellitus (DM) , fibroscan > 6 kilopascal (kPa), platelet count < 150,000 /ml, and other patients suspected to progress clinically or requiring diagnosis

• Patients who underwent (<6 months) or will undergo US-guided liver biopsy

Exclusion Criteria:

• Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis)

• Excessive alcohol consumption (weekly men >140g and women >70g)

• Fatty liver due to medication

• Decompensated liver cirrhosis

• Contraindication to magnetic resonance imager(MRI)

• Malignancy or other systemic disease

• Pregnancy

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Intervention

Diagnostic Test:
• Imaging and serologic evaluation of fibrosis and steatosis
Imaging evaluation: Fibroscan, MRI scan for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients Serologic evaluation: serologic test for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12. — View Citation

Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. — View Citation

Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. — View Citation

Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RN, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995 Jun;22(6):696-9. Review. — View Citation

Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. — View Citation

Park YS, Lee CH, Kim JH, Kim BH, Kim JH, Kim KA, Park CM. Effect of Gd-EOB-DTPA on hepatic fat quantification using high-speed T2-corrected multi-echo acquisition in (1)H MR spectroscopy. Magn Reson Imaging. 2014 Sep;32(7):886-90. doi: 10.1016/j.mri.2014.04.010. Epub 2014 Apr 24. — View Citation

Piechnik SK, Ferreira VM, Dall'Armellina E, Cochlin LE, Greiser A, Neubauer S, Robson MD. Shortened Modified Look-Locker Inversion recovery (ShMOLLI) for clinical myocardial T1-mapping at 1.5 and 3 T within a 9 heartbeat breathhold. J Cardiovasc Magn Reson. 2010 Nov 19;12:69. doi: 10.1186/1532-429X-12-69. — View Citation

Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14. — View Citation

SCHEUER PJ, WILLIAMS R, MUIR AR. Hepatic pathology in relatives of patients with haemochromatosis. J Pathol Bacteriol. 1962 Jul;84:53-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of scoring system for diagnosis of NASH	Development of scoring system for diagnosis of NASH using cox regression analysis	up to 24 months
Secondary	Evaluation of hepatic fibrosis using fibroscan	Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa)	up to 24 months
Secondary	Evaluation of hepatic steatosis using fibroscan	Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m)	up to 24 months
Secondary	Evaluation of hepatic fibrosis using MRI	Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa)	up to 24 months
Secondary	Evaluation of hepatic steatosis using MRS	Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%)	up to 24 months
Secondary	Evaluation of hepatic fibrosis using serologic marker	Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI)	up to 24 months