Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)

NCT03375008 | Completed

• 1 other identifier: KUGH16184
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate feasibility of using multiparametric Magnetic resonance(MR) imaging to predict nonalcoholic steatohepatitis(NASH)
2. 2.To develop non-invasive diagnosis tool using multiparametric Magnetic resonance(MR) imaging for nonalcoholic steatohepatitis(NASH)

Conditions

Nonalcoholic Steatohepatitis

Keywords

Magnetic resonance imager(MRI); Nonalcoholic fatty liver disease(NAFLD); Imaging diagnostic

Outcome Measures

Primary Outcomes (1)

• Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)

  Development of non-invasive magnetic resonance imaging diagnostic model for NASH using linear regression analysis 1. Linear regression analysis using three magnetic resonance(MR) parameters 1) Fat signal fraction measured on MR spectroscopy (unit: %) 2) Liver stiffness measured on MR elastography (unit: kPa) 3) T1 relaxation time measured on T1 mapping (unit: msec) → Development of linear equation for NAFLD activity score (NAS) and Steatosis, Activity, Fibrosis (SAF) score 2. Fitting of observed values (NAS, SAF score) and predicted values (NAS, SAF score) → Obtaining R square (R2) (Unit: none)

  up to 23 month

Secondary Outcomes (5)

• Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy

  During scanning, up to 15 seconds

• Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE)

  During scanning, up to 20 seconds

• Fibrosis imaging(2) : T1 relaxation time measured on T1 mapping

  During scanning, up to 20 seconds

• Histologic interpretation(1) : Nonalcoholic fatty liver disease activity score (NAS)

  Up to a week

• Histologic interpretation(1) : Steatosis, Activity, Fibrosis (SAF) score

  Up to a week

Study Arms (1)

Imaging diagnostic and biopsy

EXPERIMENTAL

47 subjects who are suspected NASH from June 2016 to December 2017.

Diagnostic Test: Imaging diagnostic and biopsy

Interventions

Imaging diagnostic and biopsy DIAGNOSTIC_TEST

Liver biopsy and MRI scan

Imaging diagnostic and biopsy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>19 years age
• Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) and fatty liver on abdominal ultrasonography
• Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH)
• Clinically suspected nonalcoholic steatohepatitis(NASH): \>40 years age, metabolic syndrome, fibrosis on transient elastography(TE, Fibroscan), or elevated Fibrosis-4(FIB-4), Aspartate aminotransferase-to-platelet ratio index(APRI), nonalcoholic fatty liver disease fibrosis score(NFS) on blood tests
• 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 sclerosis)
• Alcohol abuse (men, \>140g/week; women, \>70g/week)
• Fatty liver due to medication
• Contraindication to magnetic resonance imager(MRI)
• Hepatocellular carcinoma
• Pregnancy

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

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: 22488764 BACKGROUND

• 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: 22343514 BACKGROUND

• 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: 24036007 BACKGROUND

• 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: 24853467 BACKGROUND

• 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: 7560864 BACKGROUND

• 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: 10484010 BACKGROUND

• 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: 14498313 BACKGROUND

• 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: 15915461 BACKGROUND

• 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: 21092095 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diagnostic Imaging; Biopsy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chang Hee Lee, MD, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 15, 2017
• Study Start: September 8, 2016
• Primary Completion: August 7, 2018
• Study Completion: August 7, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)