Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation and agreement between UDFF and PDFF
研究概览
简要总结
This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.
详细描述
This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.
The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.
Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 and younger than 80 years
- •Patients suspected of MASLD
- •Patients who are planned to undergo either liver biopsy or surgery
- •Patients willing to provide written informed consent.
排除标准
- •Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
- •Patients with previous liver surgery or transplantation
- •Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
- •Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.
结局指标
主要结局
Correlation and agreement between UDFF and PDFF
时间窗: During procedure
Spearman rank correlation coefficient Intraclass correlation coefficient (ICC) with a 2-way random effects model for absolute agreement Bland-Altman plots
Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference
时间窗: During procedure
AUROC analysis
次要结局
- Intra-observer and inter-observer agreement(During procedure)
- UDFF performance in different fibrosis stages(During procedure)
研究者
So Yeon Kim
MD, PhD
Asan Medical Center