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

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ClinicalTrials.gov Identifier: NCT03725631
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jong Eun Yeon, Korea University Guro Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019


Arm Intervention/treatment
Experimental: Biopsy proven NAFLD patients
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
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 Measures :
  1. Development of scoring system for diagnosis of NASH [ Time Frame: up to 24 months ]
    Development of scoring system for diagnosis of NASH using cox regression analysis


Secondary Outcome Measures :
  1. Evaluation of hepatic fibrosis using fibroscan [ Time Frame: up to 24 months ]
    Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa)

  2. Evaluation of hepatic steatosis using fibroscan [ Time Frame: up to 24 months ]
    Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m)

  3. Evaluation of hepatic fibrosis using MRI [ Time Frame: up to 24 months ]
    Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa)

  4. Evaluation of hepatic steatosis using MRS [ Time Frame: up to 24 months ]
    Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%)

  5. Evaluation of hepatic fibrosis using serologic marker [ Time Frame: up to 24 months ]
    Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725631


Contacts
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Contact: Jong Eun Yeon, MD, Ph.D. 82-2-2626-3010 jeyyeon@hotmail.com
Contact: Young Sun Lee, MD 82-2-2626-3013 lys810@hanmail.net

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Contact: Ji-young Lee    82-2-2626-2279    ljy@kumc.or.kr   
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
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Principal Investigator: Jong Eun Yeon, MD, Ph.D. Prefessor

Publications:

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Responsible Party: Jong Eun Yeon, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03725631     History of Changes
Other Study ID Numbers: 2016GR0302
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jong Eun Yeon, Korea University Guro Hospital:
Magnetic resonance imager(MRI)
Nonalcoholic fatty liver disease(NAFLD)
Biomarker

Additional relevant MeSH terms:
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Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases