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

Primary Purpose

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Imaging and serologic evaluation of fibrosis and steatosis
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonalcoholic Fatty Liver focused on measuring Magnetic resonance imager(MRI), Nonalcoholic fatty liver disease(NAFLD), Biomarker

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Guro HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy proven NAFLD patients

Arm Description

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

Outcomes

Primary Outcome Measures

Development of scoring system for diagnosis of NASH
Development of scoring system for diagnosis of NASH using cox regression analysis

Secondary Outcome Measures

Evaluation of hepatic fibrosis using fibroscan
Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa)
Evaluation of hepatic steatosis using fibroscan
Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m)
Evaluation of hepatic fibrosis using MRI
Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa)
Evaluation of hepatic steatosis using MRS
Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%)
Evaluation of hepatic fibrosis using serologic marker
Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI)

Full Information

First Posted
August 20, 2018
Last Updated
October 29, 2018
Sponsor
Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03725631
Brief Title
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD
Official Title
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Keywords
Magnetic resonance imager(MRI), Nonalcoholic fatty liver disease(NAFLD), Biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy proven NAFLD patients
Arm Type
Experimental
Arm Description
150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018.
Intervention Type
Diagnostic Test
Intervention Name(s)
Imaging and serologic evaluation of fibrosis and steatosis
Intervention Description
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
Primary Outcome Measure Information:
Title
Development of scoring system for diagnosis of NASH
Description
Development of scoring system for diagnosis of NASH using cox regression analysis
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Evaluation of hepatic fibrosis using fibroscan
Description
Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa)
Time Frame
up to 24 months
Title
Evaluation of hepatic steatosis using fibroscan
Description
Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m)
Time Frame
up to 24 months
Title
Evaluation of hepatic fibrosis using MRI
Description
Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa)
Time Frame
up to 24 months
Title
Evaluation of hepatic steatosis using MRS
Description
Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%)
Time Frame
up to 24 months
Title
Evaluation of hepatic fibrosis using serologic marker
Description
Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI)
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Eun Yeon, MD, Ph.D.
Phone
82-2-2626-3010
Email
jeyyeon@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Young Sun Lee, MD
Phone
82-2-2626-3013
Email
lys810@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Eun Yeon, MD, Ph.D.
Organizational Affiliation
Prefessor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-hoe Song, MBE
Phone
82-2-2626-1635
Email
ssessong@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji-young Lee
Phone
82-2-2626-2279
Email
ljy@kumc.or.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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22488764
Citation
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Results Reference
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Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD

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