Accurate Point of Care Liver Disease Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Agreement of LiverScope® measurements compared to conventional MR
研究概览
简要总结
This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use.
In this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations.
Study participants will be asked to complete a one-time visit which includes:
- LiverScope exam
- MR exam
- FibroScan exam (optional)
- Blood draw
- Completion of study questionnaires
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Known or clinically suspected MASLD
- •BMI greater than 27 kg/m^2 and less than 45 kg/m^2 at the time of referral
- •Ability to lie on LiverScope® device table for about 60 minutes
- •Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams
- •Willing and able to undergo all study procedures
排除标准
- •UCSD study personnel or Livivos study personne
- •Contraindications to MR
- •Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.
- •Known chronic liver disease other than MASLD
研究组 & 干预措施
Single arm
This is a single arm study in which all participants undergo the same research procedures.
干预措施: LiverScope® exam (Diagnostic Test)
Single arm
This is a single arm study in which all participants undergo the same research procedures.
干预措施: MR exam (Diagnostic Test)
Single arm
This is a single arm study in which all participants undergo the same research procedures.
干预措施: Blood draw (Diagnostic Test)
Single arm
This is a single arm study in which all participants undergo the same research procedures.
干预措施: Body measurements (Other)
Single arm
This is a single arm study in which all participants undergo the same research procedures.
干预措施: Questionnaire (Other)
结局指标
主要结局
Agreement of LiverScope® measurements compared to conventional MR
时间窗: Up to 3 months
Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver.
Repeatability and reproducibility of LiverScope® measurements
时间窗: Up to 3 months
Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®.
次要结局
未报告次要终点
研究者
Claude Sirlin
Professor of Radiology
University of California, San Diego