Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Development and Evaluation of models for liver fat estimation.
研究概览
简要总结
This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.
The investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.
Our goals are:
- To assess the accuracy of the advanced ultrasound analysis techniques in children
- To implement and assess these advanced technique on small handheld ultrasound devices, if possible
详细描述
Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.
Our study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.
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
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 9 to 18 years
- •Presence of risk factors for having MASLD
- •Ability and willingness of participant or legal guardian/parent to give written informed consent
- •Participant is willing to give written assent
- •Able and willing to undergo all study procedures
排除标准
- •Known liver disease other than MASLD
- •Pregnant or trying to become pregnant
- •Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference > 140 cm, claustrophobie, and/or metal implants.
结局指标
主要结局
Development and Evaluation of models for liver fat estimation.
时间窗: 5 years
We plan to develop and evaluate models for estimating liver fat fraction and classifying the presence or absence of steatotic liver disease using QUS data.
次要结局
未报告次要终点
研究者
Claude Sirlin
Professor of Radiology
University of California, San Diego