Development of Non-invasive Magnetic Resonance Imaging Diagnostic Method for Nonalcoholic Steatohepatitis(NASH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)
研究概览
简要总结
- To evaluate feasibility of using multiparametric Magnetic resonance(MR) imaging to predict nonalcoholic steatohepatitis(NASH)
- To develop non-invasive diagnosis tool using multiparametric Magnetic resonance(MR) imaging for nonalcoholic steatohepatitis(NASH)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Imaging diagnostic and biopsy
47 subjects who are suspected NASH from June 2016 to December 2017.
干预措施: Imaging diagnostic and biopsy (Diagnostic Test)
结局指标
主要结局
Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)
时间窗: 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)
次要结局
- Histologic interpretation(1) : Steatosis, Activity, Fibrosis (SAF) score(Up to a week)
- Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE)(During scanning, up to 20 seconds)
- Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy(During scanning, up to 15 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)
研究者
Chang Hee Lee
Professor
Korea University Guro Hospital