Development of a Magnetic Resonance Imaging (MRI) Based Biomarker for Detecting Fibrosis and Classifying Fibrosis Stage in Adults with Biopsy Proven Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Relationship between liver fibrosis assessment using analysed Magnetic Resonance Imaging (MRI) parameters for detection and staging of liver fibrosis
研究概览
简要总结
There is an unmet need for novel, more accurate non-invasive techniques including imaging based techniques in order to improve fibrosis assessment and patient outcomes.
Development of such biomarkers has been highlighted by the FDA and other regulators as a critical requirement to accelerate drug development for the treatment of NASH NAFLD MAFLD.
An accurate non invasive predictive method for assessing liver fibrosis has appeal and will gain more acceptance among patients and clinicians for disease staging, determine prognosis, guiding treatment strategies, and provides standards for inclusion and end points assessment in clinical trials to avoid unnecessary liver biopsies.
To meet this unmet need, this study aims to develop predictive models of liver fibrosis based on MRI data analysis outcomes using liver biopsy as the reference standard.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Known diagnosis of chronic liver disease.
排除标准
- •Inadequate biopsy length for histology.
结局指标
主要结局
Relationship between liver fibrosis assessment using analysed Magnetic Resonance Imaging (MRI) parameters for detection and staging of liver fibrosis
时间窗: Within 183 days of confirmed fibrosis in CLD patients
次要结局
- To determine thresholds optimising the sensitivity of Liver Fibrosis-MRI to screen patients & optimising specificity to confirm liver fibrosis stage(Within 183 days of confirmed fibrosis in CLD patients.)
研究者
Nagaraj Vayyavuru
Vichag Limited