Evaluation of a Quantitative Ultrasound Model(DeepUSFF) for Liver Fat Quantification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Prospective Study Using MRI-PDFF as the Reference Standard
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Correlation between Ultrasound Fat Fraction and MRI-PDFF
研究概览
简要总结
This multicenter prospective study aims to evaluate the correlation between quantitative ultrasound fat fraction (USFF) and MRI-PDFF (Proton Density Fat Fraction) for liver fat quantification in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The study will compare the diagnostic accuracy of quantitative ultrasound imaging against MRI-PDFF as the reference standard.
详细描述
Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common liver disease requiring accurate assessment for treatment planning and monitoring. While liver biopsy remains the gold standard, it is invasive with potential complications. MRI-PDFF has emerged as an accurate non-invasive method, but it is expensive and has limited accessibility. Quantitative ultrasound techniques using RF data have been developed to provide objective liver fat assessment.
Objective
To prospectively evaluate the correlation between quantitative ultrasound-derived fat fraction (DeepUSFF) and MRI-PDFF in patients with suspected MASLD across different ethnicities and varying degrees of hepatic steatosis.
Methods: This prospective multicenter study will recruit 62 patients (31 from each participating center) suspected of having MASLD. All participants will undergo both quantitative ultrasound examination and non-contrast liver MRI within one week. The primary endpoint is the correlation coefficient between ultrasound fat fraction and MRI-PDFF. Secondary endpoints include diagnostic accuracy metrics and inter-observer reproducibility.
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
- 否
入选标准
- •Patients with clinically suspected MASLD based on abnormal ultrasound or liver function tests requiring liver ultrasound or MRI examination
- •BMI ≥25 kg/m² or waist circumference >90 cm (male) or >80 cm (female), suggesting high likelihood of fatty liver disease
- •Living liver transplant donors requiring preoperative liver ultrasound or MRI examination
- •Age ≥18 years
- •Understanding and signing informed consent
排除标准
- •Significant alcohol consumption in the past 2 years:
- •Male: ≥30-60g/day average alcohol intake Female: ≥20-50g/day average alcohol intake
- •Chronic liver disease:
- •Histological diagnosis of chronic liver disease HBsAg positive Anti-HCV positive Other suspected chronic liver diseases
- •Liver failure:
- •Serum albumin <3.2 g/dL INR >1.3 Direct bilirubin >1.3 mg/dL
- •History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction
- •History of liver cancer diagnosis or treatment
- •History of liver surgery
- •Pregnancy
- •Inability to obtain adequate liver ultrasound imaging:
- •Patient cooperation impossible Inadequate image acquisition as determined by investigator
- •Inability to obtain adequate liver MRI imaging: Patient cooperation impossible Severe obesity preventing MRI examination MRI contraindications (cardiac pacemaker, etc.) Other factors preventing adequate imaging as determined by investigator
研究组 & 干预措施
Quantitative Ultrasound Fat Fraction Assessment
All enrolled participants undergo two non-invasive diagnostic imaging procedures within a 7-day window for direct comparison of liver fat quantification methods:
- **Quantitative Ultrasound Examination**: Performed using Samsung RS85 ultrasound system with CA1-7S convex probe to obtain ultrasound fat fraction (DeepUSFF). The examination includes standard liver ultrasound assessment followed by quantitative fat fraction measurements in the right hepatic lobe (S5 or S8 segments). Multiple measurements (5 per session) are obtained during breath-holding to ensure reproducibility. Total examination time: approximately 10-15 minutes.
- **Non-contrast Liver MRI with PDFF**: Magnetic resonance imaging with proton density fat fraction (MRI-PDFF) sequence and MR elastography performed within 7 days of the ultrasound examination. The MRI protocol includes breath-hold sequences (10-20 seconds each) for optimal image quality. Total examination time: approximately 15 minutes.
干预措施: Quantitative ultrasound (DeepUSFF) (Device)
结局指标
主要结局
Correlation between Ultrasound Fat Fraction and MRI-PDFF
时间窗: At enrollment (single time point assessment)
earson correlation coefficient between quantitative ultrasound fat fraction (USFF) and MRI-PDFF
次要结局
未报告次要终点
研究者
Jeong Min Lee
professor
Seoul National University Hospital