Suspended

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

What is being tested

Imaging and serologic evaluation of fibrosis and steatosis

Diagnostic Test

Who is being recruted

Digestive System Diseases+1

+ Fatty Liver

+ Liver Diseases

Over 19 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: September 2016

See protocol details

Summary

Principal SponsorKorea University Guro Hospital

Study ContactJong Eun Yeon, MD, Ph.D.More contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2016

Actual date on which the first participant was enrolled.

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

NCT03725631

Principal SponsorKorea University Guro Hospital

Study ContactJong Eun Yeon, MD, Ph.D.More contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFatty LiverLiver DiseasesNon-alcoholic Fatty Liver Disease

Criteria

4 inclusion criteria required to participate

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

7 exclusion criteria prevent from participating

Pregnancy

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Korea University Guro Hospital

Seoul, South KoreaOpen Korea University Guro Hospital in Google Maps

SuspendedOne Study Center