Determination of Normal Liver Stiffness by MR Elastography in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Liver Stiffness
研究概览
简要总结
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.
详细描述
MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 7-17 years
- •No documented history of liver diseases
- •English speaking
排除标准
- •NPO less than 4 hours
- •Body mass index <10th or > 85th percentile for age
- •Documented history of liver disease
- •Pregnancy
- •Inability to lie still for duration of the MRI
- •Inability to breath hold for the duration of the 15-20 second MR elastography sequence
- •Standard contraindication to MRI (implanted hardware, etc.)
- •Requirement of sedation or general anesthesia for MRI
- •Abnormality of any measured liver function test
- •Liver fat fraction >5% by MRI PDFF
研究组 & 干预措施
Normals
Will receive an MRI and a blood draw
干预措施: MRI (Device)
Normals
Will receive an MRI and a blood draw
干预措施: Blood draw (Diagnostic Test)
结局指标
主要结局
Liver Stiffness
时间窗: 30 minutes
Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI. Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE
次要结局
- Cross-platform Variability(30 minutes)
- Cross-field Strength(30 minutes)
- Sex-related Differences(30 minutes)