Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
研究概览
简要总结
Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis
详细描述
Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).
The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.
Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.
At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.
Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
- •signature of written consent
排除标准
- •Contra-indications to MRI
- •Refusal of protocol
- •underage patients and protected adults
结局指标
主要结局
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
时间窗: at day 1
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
次要结局
- Measurement of intrahepatic iron(at day 1)
- Measurement of intrahepatic fibrosis(at day 1)
- Measurement of fat in different hepatic segments(at day 1)
- Concordance between observers(at day 1)
