STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
The assessment of liver fat content is important in patients suspected of or diagnosed with chronic liver disease. Non-alcoholic fatty liver disease (NAFLD) is defined by the presence of hepatic fat content ≥5% of hepatocytes. NAFLD is currently the most common chronic liver disease worldwide with an estimated prevalence of 5-30% in the general population and in 55% up to 80% of patients with type 2 diabetes. New ultrasound methods for a non-invasive and quantitative assessment of the liver fat content have recently been developed. They are based on the estimation of the attenuation coefficient of the ultrasound beam.
Our group has conducted studies to evaluate the performance of the attenuation coefficient available on the Aplio i800 ultrasound system (ATI, Canon Medical Systems). The Aplio i800 ultrasound system has already a CE mark, and is available at our Ultrasound Unit for research purposes. ATI has showed a high accuracy for the quantification of liver fat, and was more accurate than the controlled attenuation parameter (CAP, FibroScan) in assessing significant steatosis. The aim of the study is therefore the optimization of the acquisition protocol of ATI measurements on the system Aplio i800, which has already a CE mark.
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
- 是
入选标准
- •Informed consent
- •Healthy adult volunteers (> 18 years)
- •Ability to suspend respiration for image acquisition
排除标准
- •Pregnancy
- •age < 18 years
- •Presence of ascites, acute viral hepatitis, transaminase flares, congestive heart failure, infiltrative diseases.
- •No major medical conditions and in particular no known hepatic diseases
- •Any other condition that, upon clinical judgment of the investigator, will make unacceptable the study participation for that individual subject
- •Consent withdrawal
研究者
Gianluigi Poma
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
