Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
研究概览
简要总结
The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.
详细描述
The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls age 7-18 years
- •Scheduled for a clinically indicated liver biopsy
- •Able to undergo MRI without sedation
- •Written informed consent from parent or legal guardian
- •Written informed assent from the child when indicated by age
排除标准
- •Renal disease with a creatinine > 2 or requiring dialysis
- •Metal, braces or other implanted devices not compatible with MRI
- •Not willing to try to hold still for an un-sedated MRI
- •Pregnancy
- •Failure to give consent or assent
结局指标
主要结局
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
时间窗: 12 months
The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.
Repeatability of HepaFat-Scan
时间窗: 12 months
Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.
Correlation between HepaFat-Scan and pathology based assessment of steatosis
时间窗: 12 months
Correlation of histologic steatosis to HepaFat-Scan measurement.
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis
时间窗: 12 months
The percent of total steatosis by MRS and computerized steatosis (computer-assisted pixel count algorithm) will be plotted and Pearson correlation coefficient will be calculated to explore their relationship.
次要结局
未报告次要终点
研究者
Miriam Vos, MD
Associate Professor
Emory University