Diagnostic performance of quantitative ultrasound parameters in assessing hepatic steatosis in NAFLD with MRI PDFF as the reference standard a prospective non randomized cohort study
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Samsung Medison Co.Ltd
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To assess the diagnostic accuracy of TAI, TSI and US Fat fraction to predict different grades of hepatic steatosis in comparison with MRI-PDFF;S2 and S3
概览
简要总结
This clinical trial evaluates the diagnostic accuracy of ultrasound techniques and features, including Total Attenuation Imaging (TAIâ„¢), Tissue Scatter Imaging (TSIâ„¢), and Ultrasound Fat Fraction (USFF), for assessing hepatic steatosis compared to MRI Proton Density Fat Fraction (MRI-PDFF). Conducted at Max Smart Super Speciality Hospital, the study involves adults clinically suspected of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). It aims to correlate TAIâ„¢ and TSIâ„¢ with MRI-PDFF, compare USFF with B-mode ultrasound for different steatosis grades, and evaluate the relationship between USFF and clinical tests. Patients are recruited based on specific inclusion and exclusion criteria, with imaging performed on the same day as hospital appointments. Primary outcomes include the diagnostic performance of the ultrasound techniques, while secondary outcomes focus on sensitivity, specificity, and correlation with MRI-PDFF and clinical tests. The study strives to improve non-invasive diagnostic methods for hepatic steatosis.
研究设计
- 研究类型
- Interventional
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who clinically suspected MASLD based on EASL–EASD–EASO Clinical Practice Guidelines for the management of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), or patients who recommended to undergo either abdominal ultrasound examination or liver MRI examination
- •Male or Female of Age ≥18 years ,
- •Individuals who have decided to participate in the clinical study on their own will and have provided the informed consent after reading/hearing and fully understanding the detailed explanations regarding the clinical study.
排除标准
- •Subject who has disagreed the signing of informed consent form for this study
- •Subject who has a history of chronic liver disease due to etiology other than MASLD.
- •Subject who had a daily alcohol consumption ⩾30 g for men and ⩾20 g for women based on EASL– ASD–EASO Clinical Practice Guidelines for the management of metabolic dysfunctionassociated steatotic liver disease (MASLD)
- •Subject who has a history of long-term use of hepatotoxic drugs.
- •Subject with acute liver failure
- •Subject who has a history of esophageal varix, hydrops abdominis, hepatic coma, as well as patents with signs of acute biliary obstruction, or those who had recent liver surgery.
- •Woman who is pregnant.
结局指标
主要结局
To assess the diagnostic accuracy of TAI, TSI and US Fat fraction to predict different grades of hepatic steatosis in comparison with MRI-PDFF;S2 and S3
时间窗: 1 year
次要结局
- Sensitivity, Specificity, Positive predictive value (PPV), Negative Predictive Value (NPV) and(accuracy of quantitative ultrasound imaging parameters according to hepatic steatosis grade)
研究者
Dr Abhishek Rajendra Agarwal
Max Smart Super speciality Hospital