NCT04180631已完成不适用
Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
研究概览
简要总结
The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
- •Signed informed consent
排除标准
- •chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
- •chronic alcoholics
- •serum alanine transaminase (ALT)>5 times the upper limit of normal within 3 months
- •previous liver surgery
- •acute hepatitis or bile duct obstruction
结局指标
主要结局
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
时间窗: 3 months
reference standard: MR spectroscopy or MRI-proton density fat fraction value
次要结局
- Correlation between S-shearwave elastography and MR elastography(3 months)
- Development and validation of deep learning model for prediction of hepatic steatosis(1 month)
- Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver(3 months)
- Intra-observer agreement of quantitative ultrasound imaging parameter(same 1 day)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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