NCT04523584已完成不适用
Ultrasound Quantification of Liver Fat
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- MRI PDFF correlation/agreement to UDFF
研究概览
简要总结
The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.
详细描述
MRI proton density fat fraction (PDFF) will serve as the reference standard for liver fat fraction measurements. The strength of agreement between ultrasound derived fat fraction (UDFF) and PDFF will be the outcome of interest for this study.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 16 years of age or older with known fatty liver disease (based upon prior MRI or ultrasound), or at risk for fatty liver disease (obese).
排除标准
- •Subject under the age of 16
- •Pregnant subject
- •Subjects who cannot cooperate with performance of the ultrasound exam
- •Subjects who cannot cooperate with performance of the MRI exam
- •Subjects who have contraindications to MRI
- •Subjects who might require sedation or anesthesia to undergo study imaging
结局指标
主要结局
MRI PDFF correlation/agreement to UDFF
时间窗: Single time point-30 minute MRI/30 minute Ultrasound
Liver fat % derived using MR PDFF will be compared to UDFF
次要结局
未报告次要终点
研究者
研究点 (1)
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