An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease (NAFLD) in Children: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions
研究概览
简要总结
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
详细描述
The severity of the obesity epidemic in the U.S., particularly in Wisconsin, is alarming, with overall overweight or obesity rates of 35% in children. [Fryar 2020,] Obesity is a major risk factor for several comorbidities, one of the most common being non-alcoholic fatty liver disease (NAFLD, also denoted steatotic liver disease). The inflammatory state known as non-alcoholic steatohepatitis (NASH) may lead to fibrosis and, if left untreated, can lead to cirrhosis, liver failure, and cancer. For these reasons, there is enormous interest in effective interventions for weight loss and reversing NAFLD. A central challenge in the development of new interventions is the need for accurate and precise biomarkers to evaluate hepatic steatosis in children.
This pilot study focuses on demonstrating the feasibility of MRI and US based liver fat quantification in children and addresses technical challenges that may limit the performance of the proposed techniques in the population of interest through the following aims:
- Aim 1: Determine the bias and precision (repeatability) of emerging free-breathing MRI-based liver fat quantification in children with obesity and controls using current breath-held methods as a reference.
- Aim 2: Determine the precision (repeatability and reproducibility) of US-based biomarkers of liver steatosis with a focus on the impact of body wall thickness on the precision of the biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 10 - 14years old
- •BMI: Case subjects: BMI>95th percentile for age and sex Healthy BMI volunteers: 5th ≤ BMI < 85th percentile for age and sex
排除标准
- •Children with contraindications to MRI.
- •Children who did not fast (verbally confirmed by children or guardian)
结局指标
主要结局
Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions
时间窗: through study enrollment (up to approximately 14 months)
Demonstrate the feasibility of MRI- and US-based liver fat quantification in children and address technical challenges that may limit the performance of the proposed techniques in the population of interest.
次要结局
- Quantitative US: Repeatability of US Measurements (same sonographer) - Attenuation Coefficient (dB/cm-MHz)(Research visit 1 (up to 14 months))
- Quantitative US: Repeatability of US Measurements (same sonographer) - Backscatter Coefficient (1/cm*sr)(Research visit 1 (up to 14 months))
- Quantitative US: Reproducibility of US Measurements (different sonographers) - Attenuation Coefficient (dB/cm-MHz)(Research visit 1 (up to 14 months))
- Quantitative US: Reproducibility of US Measurements (different sonographers) - Backscatter Coefficient (1/cm*sr)(Research visit 1 (up to 14 months))
- MRI: Bias reported as difference in mean error in Percent Liver Fat measured from free-breathing MRI method and reference breath-held MRI method(Research visit 1 (up to 14 months))
- MRI: Precision measured by Test-Retest of Percent Liver Fat(Research visit 1 (up to 14 months))
- MRI: Bias reported as difference in mean error in Percent Liver Fat measured from free-breathing MRI method and reference breath-held MRI method(Research visit 1 (up to 14 months))
- MRI: Precision measured by Test-Retest of Percent Liver Fat(Research visit 1 (up to 14 months))
- Quantitative US: Repeatability of US Measurements (same sonographer) - Attenuation Coefficient (dB/cm-MHz)(Research visit 1 (up to 14 months))
- Quantitative US: Repeatability of US Measurements (same sonographer) - Backscatter Coefficient (1/cm*sr)(Research visit 1 (up to 14 months))
- Quantitative US: Reproducibility of US Measurements (different sonographers) - Attenuation Coefficient (dB/cm-MHz)(Research visit 1 (up to 14 months))
- Quantitative US: Reproducibility of US Measurements (different sonographers) - Backscatter Coefficient (1/cm*sr)(Research visit 1 (up to 14 months))