Clinical trial NCT03375008: Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)
Official title: Development of Non-invasive Magnetic Resonance Imaging Diagnostic Method for Nonalcoholic Steatohepatitis(NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Steatohepatitis
Keywords: Magnetic resonance imager(MRI)
Nonalcoholic fatty liver disease(NAFLD)
Imaging diagnostic
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

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).

Eligibility 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

Primary outcomes:
measure: Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)
timeFrame: up to 23 month
Secondary outcomes:
measure: Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy
timeFrame: During scanning, up to 15 seconds
measure: Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE)
timeFrame: During scanning, up to 20 seconds
measure: Fibrosis imaging(2) : T1 relaxation time measured on T1 mapping
timeFrame: During scanning, up to 20 seconds
measure: Histologic interpretation(1) : Nonalcoholic fatty liver disease activity score (NAS)
timeFrame: Up to a week
measure: Histologic interpretation(1) : Steatosis, Activity, Fibrosis (SAF) score
timeFrame: Up to a week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Professor
name: Chang Hee Lee, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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