The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
研究概览
简要总结
The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values 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 known NAFLD or suspected of having NAFLD
- •Patients who are scheduled hepatectomy for living donor liver donation
- •aged ≥ 18 years who are willing and able to complete all procedures
排除标准
- •excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
- •clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
- •use of steatogenic or hepatotoxic medication
- •evidence of decompensated liver disease
- •history of liver surgery
- •contraindication to MRI
- •any other condition believed by investigator to affect a patients' compliance, or completion of the study
研究组 & 干预措施
quantitative ultrasound imaging parameters
quantitative ultrasound imaging parameters
- tissue attenuation imaging (TAI) parameter
- tissue scatter-distribution imaging (TSI) parameter
- Hepatorenal index (semi-auto, EzHRI)
干预措施: Quantitative US (Samsung Medison, RS85A) (Diagnostic Test)
结局指标
主要结局
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
时间窗: 1 month
Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF \>5 percent patients
次要结局
- Correlation of QUS parameters and MR fat fraction(1 month)
- Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction(1 month)
- Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)(1 month)
- Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)(1 month)
- Intra-observer agreement of quantitative US parameters(1 day)
- Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)(1 month)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital