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

Study Overview
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Brief Summary
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To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker To develop non-invasive diagnosis marker for NASH and advanced fibrosis

Detailed Description
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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).

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

Conditions
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Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy proven NAFLD patients<br>150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018. | Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of hepatic fibrosis using fibroscan | Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa) | up to 24 months | 
| Evaluation of hepatic steatosis using fibroscan | Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m) | up to 24 months | 
| Evaluation of hepatic fibrosis using MRI | Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa) | up to 24 months | 
| Evaluation of hepatic steatosis using MRS | Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%) | up to 24 months | 
| Evaluation of hepatic fibrosis using serologic marker | Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI) | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imager(MRI), Nonalcoholic fatty liver disease(NAFLD), Biomarker