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Trial record 7 of 748 for:    "Visceral steatosis"

Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT03375008
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Hee Lee, Korea University Guro Hospital

Brief 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)

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Diagnostic Test: Imaging diagnostic and biopsy Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of Non-invasive Magnetic Resonance Imaging Diagnostic Method for Nonalcoholic Steatohepatitis(NASH)
Actual Study Start Date : September 8, 2016
Estimated Primary Completion Date : August 7, 2018
Estimated Study Completion Date : August 7, 2018


Arm Intervention/treatment
Experimental: Imaging diagnostic and biopsy
40 subjects who are suspected NASH from June 2016 to December 2017.
Diagnostic Test: Imaging diagnostic and biopsy
Liver biopsy and MRI scan




Primary Outcome Measures :
  1. Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH) [ Time Frame: up to 23 month ]

    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)


Secondary Outcome Measures :
  1. Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy [ Time Frame: During scanning, up to 15 seconds ]

    * 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
    2. 15 x 15 x 15-mm square-shaped region-of-interest(ROI) → Right hepatic lobe
    3. 3 times measurement → mean value was used as a representative value
    4. unit: percentage (%)
    5. 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)

  2. Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE) [ Time Frame: During scanning, up to 20 seconds ]

    * 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)

  3. Fibrosis imaging(2) : T1 relaxation time measured on T1 mapping [ Time Frame: During scanning, up to 20 seconds ]

    * 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)

  4. Histologic interpretation(1) : Nonalcoholic fatty liver disease activity score (NAS) [ Time Frame: Up to a week ]
    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

  5. Histologic interpretation(1) : Steatosis, Activity, Fibrosis (SAF) score [ Time Frame: Up to a week ]
    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



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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:

  1. Patients >19 years age
  2. Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) and fatty liver on abdominal ultrasonography
  3. 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
  4. Patients who underwent (<6 months) or will undergo US-guided liver biopsy

Exclusion Criteria:

  1. Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary sclerosis)
  2. Alcohol abuse (men, >140g/week; women, >70g/week)
  3. Fatty liver due to medication
  4. Contraindication to magnetic resonance imager(MRI)
  5. Hepatocellular carcinoma
  6. 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): NCT03375008


Contacts
Contact: Chang Hee Lee, MD, Ph.D. 82-2-2626-3212 chlee86@korea.ac.kr
Contact: Jeong Woo Kim, MD 82-2-2626-1338 pridebio@naver.com

Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Guro-gu, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Principal Investigator: Chang Hee Lee, MD, Ph.D. Professor

Publications:

Responsible Party: Chang Hee Lee, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03375008     History of Changes
Other Study ID Numbers: KUGH16184
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Chang Hee Lee, Korea University Guro Hospital:
Magnetic resonance imager(MRI)
Nonalcoholic fatty liver disease(NAFLD)
Imaging diagnostic

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