Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique
研究概览
简要总结
The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.
详细描述
Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed or suspected to have non-alcoholic fatty liver disease
- •Patients 18-70 years of age
- •be able to understand and sign on written informed consent
- •able to undergo ultrasound and MRI examinations
排除标准
- •any metal or electronic implants including but not limited to pacemakers, clips, hips
- •known history of pregnancy or becoming pregnant during study period
- •unable to understand and sign on written informed consent
- •intolerant to ultrasound and/or MRI examinations
研究组 & 干预措施
Study Group
The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared.
干预措施: Thermo-acuostic image acquisition of liver (Diagnostic Test)
Study Group
The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared.
干预措施: MRI-PDFF estimation of hepatic fat (Diagnostic Test)
结局指标
主要结局
Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique
时间窗: one year
The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan.
次要结局
- Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.(One year)
- Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver(One year)
研究者
Achuthan Sourianarayanane
Assistant Professor
Medical College of Wisconsin