Prospective Comparison Between Transient Elastography (TE), Shear Wave Elastography (SWE) and Magnetic Resonance Elastography (MRE) for Non-invasive Assessment of Liver Fibrosis in Patients Affected by Chronic Viral Hepatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- liver stiffness
研究概览
简要总结
The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).
详细描述
Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE.
Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities.
Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV).
排除标准
- •contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)
结局指标
主要结局
liver stiffness
时间窗: 18 months
liver stiffness is indicated in kPa
次要结局
- liver steatosis(18 months)
- liver iron overload(18 months)
研究者
Gian Andrea Rollandi
Direttore medico responsabile S.C. Radiodiagnostica
Ente Ospedaliero Ospedali Galliera