Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Agreement in Measured Liver Stiffness Between ARFI and MRE
研究概览
简要总结
A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.
详细描述
ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.
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
- 1 Day 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 25 years old with chronic liver disease
排除标准
- •Subjects without clinically ordered MRE
- •Subjects who cannot cooperate with performance of the short ARFI exam
研究组 & 干预措施
Study cohort
Acoustic Radiation Force Imaging
干预措施: Acoustic Radiation Force Imaging (Device)
结局指标
主要结局
Agreement in Measured Liver Stiffness Between ARFI and MRE
时间窗: Within 24 hours
The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis
次要结局
未报告次要终点
