NCT03725631

Brief Summary

  1. 1.To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker
  2. 2.To develop non-invasive diagnosis marker for NASH and advanced fibrosis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

August 20, 2018

Last Update Submit

October 29, 2018

Conditions

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

Keywords

Magnetic resonance imager(MRI)Nonalcoholic fatty liver disease(NAFLD)Biomarker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Evaluation of hepatic fibrosis using fibroscan

    up to 24 months

  • Evaluation of hepatic steatosis using fibroscan

    up to 24 months

  • Evaluation of hepatic fibrosis using MRI

    up to 24 months

  • Evaluation of hepatic steatosis using MRS

    up to 24 months

  • Evaluation of hepatic fibrosis using serologic marker

    up to 24 months

Study Arms (1)

Biopsy proven NAFLD patients

EXPERIMENTAL

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

Interventions

Imaging and serologic evaluation of fibrosis and steatosisDIAGNOSTIC_TEST

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

Biopsy proven NAFLD patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (9)

  • 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. No abstract available.

    PMID: 22488764BACKGROUND

  • 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.

    PMID: 22343514BACKGROUND

  • 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.

    PMID: 24036007BACKGROUND

  • 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.

    PMID: 24853467BACKGROUND

  • 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. doi: 10.1016/0168-8278(95)80226-6. No abstract available.

    PMID: 7560864BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.1999.01377.x.

    PMID: 10484010BACKGROUND

  • SCHEUER PJ, WILLIAMS R, MUIR AR. Hepatic pathology in relatives of patients with haemochromatosis. J Pathol Bacteriol. 1962 Jul;84:53-64. No abstract available.

    PMID: 14498313BACKGROUND

  • 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. doi: 10.1002/hep.20701.

    PMID: 15915461BACKGROUND

  • 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(1):69. doi: 10.1186/1532-429X-12-69.

    PMID: 21092095BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jong Eun Yeon, MD, Ph.D.

    Prefessor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Eun Yeon, MD, Ph.D.

CONTACT

82-2-2626-3010jeyyeon@hotmail.com

Young Sun Lee, MD

CONTACT

82-2-2626-3013lys810@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

October 31, 2018

Study Start

September 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)