Exploratory Study of MRI Biomarkers of NASH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
研究概览
简要总结
Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.
NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.
Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.
Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.
There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
- •Adult patient
- •Free, informed and express (oral) consent of the patient to participate in the study
排除标准
- •Contraindication to MRI
- •Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
- •Pregnant, parturient and breastfeeding woman
- •Person deprived of liberty by judicial or administrative decision
- •Person under compulsion to psychiatric care
- •Person subject to a legal protection measure
- •Person not affiliated or not covered by a social security scheme.
研究组 & 干预措施
Open label
干预措施: Quantitative MRI sequences (Device)
结局指标
主要结局
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
时间窗: the outcome measurment is performed once during MRI
NASH is defined by histological criteria
次要结局
未报告次要终点