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Nonalcoholic SteatohepatitisNCT03375008

Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)

A study testing Imaging diagnostic and biopsy in people with Nonalcoholic Steatohepatitis, run by Korea University Guro Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
Imaging diagnostic and biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteSouth Korea
Study dates
8 Sep 2016to 7 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

Other trials in South Korea

About this study

Official title: Development of Non-invasive Magnetic Resonance Imaging Diagnostic Method for Nonalcoholic Steatohepatitis(NASH)

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

Nonalcoholic steatohepatitis(NASH) is a severe form of nonalcoholic fatty liver disease(NAFLD). The causes are known to be associated with metabolic diseases such as obesity, insulin resistance type 2 diabetes, and hypercholesterolemia. Histologically, it is characterized by steatosis, hepatocellular injury, and inflammation and fibrosis of the liver parenchyma. Nonalcoholic steatohepatitis (NASH) may progress to cirrhosis and hepatocellular carcinoma(HCC) may develop even in patients without viral hepatitis, therefore there have been much interest and many researches in causation and diagnosis for nonalcoholic steatohepatitis(NASH).

Liver biopsy remains the gold standard for the diagnosis of nonalcoholic fatty liver disease(NAFLD) and is the only reliable method for differentiating nonalcoholic steatohepatitis(NASH) from simple steatosis. However, liver biopsy has several drawbacks, including invasiveness, potential complications such as excessive bleeding and death, sampling error, and inter- and intra-observer variability.

Magnetic resonance(MR) imaging has been used as a multiparametric imaging tool with which to evaluate steatosis by chemical shift imaging andm magnetic resonance(MR) spectroscopy, and fibrosis by magnetic resonance(MR) elastography and T1 mapping. To the best of our knowledge, there is no accurate imaging diagnostic tool for nonalcoholic steatohepatitis(NASH), therefore the investigators aimed to develop non-invasive imaging diagnostic model using multiparametric magnetic resonance imager(MRI).

Being tested
Imaging diagnostic and biopsy
Keywords
Magnetic resonance imager(MRI), Nonalcoholic fatty liver disease(NAFLD), Imaging diagnostic
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imaging diagnostic and biopsyDiagnostic test

    Liver biopsy and MRI scan

Study groups in NCT03375008
Study groupRoleWhat they receive
Imaging diagnostic and biopsyExperimental47 subjects who are suspected NASH from June 2016 to December 2017.
Receives: Diagnostic Test: Imaging diagnostic and biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: up to 23 month

Secondary outcomes (5)

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

    • Fat signal fraction measured on magnetic resonance(MR) spectroscopy
    1. high speed T2-corrected multi-echo (HISTO) MR spectroscopic technique
    • multiple short echo time : correction of T2 bias
    • long repetition time: correction of T1 bias
    1. 15 x 15 x 15-mm square-shaped region-of-interest(ROI) → Right hepatic lobe
    2. 3 times measurement → mean value was used as a representative value
    3. unit: percentage (%)
    4. Receiver operating characteristic (ROC) curve analysis for steatosis grade (0-3) → Obtaining cut-off values of each steatosis grade and area under the curve (AUC)

    Measured: During scanning, up to 15 seconds

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

    • Magnetic resonance elastography(MRE)
    1. 60 Hz acoustic wave
    2. Four slices were obtained for each magnetic resonance elastography(MRE) examination
    3. Stiffness maps (elastograms) for each magnetic resonance elastography(MRE) slices were automatically generated
    4. free-hand region-of-interest (ROI) on the right hepatic lobe
    5. 5 times measurement → mean value was used as a representative value
    6. unit: kilopascal (kPa)
    7. Receiver operating characteristic (ROC) curve analysis for fibrosis grade (0-4) → Obtaining cut-off values of each fibrosis grade and area under the curve (AUC)

    Measured: During scanning, up to 20 seconds

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

    • T1 mapping
    1. Shortened Modified Look Locker Inversion (shMOLLI) recovery sequence
    2. Four slices were obtained for each T1 map
    3. Oval-shaped region-of-interest (ROI) in the right hepatic lobe
    4. 5 times measurement → mean value was used as a representative value
    5. unit: millisecond (msec)
    6. Receiver operating characteristic (ROC) curve analysis for ballooning (0-2), lobular inflammation (0-3), fibrosis grade (0-4) → Obtaining cut-off values of each grade and area under the curve (AUC)

    Measured: During scanning, up to 20 seconds

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

    1. the sum of each histological component semiquantitatively evaluated as follows: steatosis (0-3), ballooning (0-2), and lobular inflammation (0-3)
    2. NAS 0-2: not considered steatohepatitis
    3. NAS 3-4: possible steatohepatitis 4/ NAS ≥5: definite steatohepatitis

    Measured: Up to a week

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

    1. steatosis (0-3), ballooning degeneration (0-2), lobular inflammation (0-2), and fibrosis (0-4).
    2. Nonalcoholic steatohepatitis(NASH): when steatosis is present and when both features of activity (ballooning and lobular inflammation) display at least grade 1
    3. Unit: None

    Measured: Up to a week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start8 Sep 2016
  3. Primary completion7 Aug 2018
  4. Study completion7 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03375008
Sponsor's protocol ID
KUGH16184
Status last verified
May 2019
First submitted
22 Nov 2017
Last updated
16 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22488764

  • 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.

    PubMed 22343514

  • 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.

    PubMed 24036007

  • 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.

    PubMed 24853467

  • 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.

    PubMed 7560864

  • 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.

    PubMed 10484010

  • 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.

    PubMed 14498313

  • 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.

    PubMed 15915461

  • 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.

    PubMed 21092095

Questions about this trial

What is this clinical trial studying?

A study testing Imaging diagnostic and biopsy in people with Nonalcoholic Steatohepatitis, run by Korea University Guro Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH) (time frame: up to 23 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03375008, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019; AzTrials last refreshed its copy on 5 Nov 2026.

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