NCT02085876Unknown不适用
Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.
研究概览
简要总结
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.
To achieve this:
- The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
- Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
- Usual blood samples will be completed by samples for the serum library
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been informed about the research
- •Patients with national health insurance cover
- •Patients who are overweight (BMI > 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT < 8 times normal values and ALAT > twice normal values) after a complete hepatopathy assessment
- •Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT < 8 times normal values and ALAT > twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.
排除标准
- •Non-corrected coagulation disorder.
- •Patients aged over 80 years
- •Patients aged less than 18 years
- •Patients without legal protection
- •Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight>150kg)
- •Patients without national health insurance cover
结局指标
主要结局
To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.
时间窗: Baselines
次要结局
- To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.(Baselines)
研究者
研究点 (1)
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