非酒精性脂肪性肝病(NAFLD)是代谢综合征的肝脏表现,全球患病率达到流行水平。尽管人群的疾病负担很高,但NAFLD患者中只有一小部分会发展为进行性肝病。目前尚无批准的药物治疗。识别那些有进行性NAFLD风险的人目前需要肝活检,这是有问题的。首先,肝活检是侵入性的,因此不适合用于影响大部分人群的NAFLD等疾病.其次,活检受采样和观察者依赖性变异性的限制,这可能导致疾病严重程度的错误分类。因此,在NAFLD的评估中,需要非侵入性生物标志物来代替肝活检。我们的研究解决了这种未满足的需求。LITMUS成像研究是一项前瞻性招募的多中心队列研究,评估磁共振成像和弹性成像,和超声弹性成像对肝组织学作为参考标准。成像生物标志物和活检在100天窗口内采集。该研究采用标准化的成像数据收集和分析流程,以及对所有提交分析的数据进行实时中央监控和质量控制流程。预计这项研究产生的高质量数据将支持临床实践的变化,以使NAFLD患者受益。研究登记:clinicaltrials.gov:NCT05479721。
Non-alcoholic fatty liver disease (NAFLD) is the liver manifestation of the metabolic syndrome with global prevalence reaching epidemic levels. Despite the high disease burden in the population only a small proportion of those with NAFLD will develop progressive liver disease, for which there is currently no approved pharmacotherapy. Identifying those who are at risk of progressive NAFLD currently requires a liver biopsy which is problematic. Firstly, liver biopsy is invasive and therefore not appropriate for use in a condition like NAFLD that affects a large proportion of the population. Secondly, biopsy is limited by sampling and observer dependent variability which can lead to misclassification of disease severity. Non-invasive biomarkers are therefore needed to replace liver biopsy in the assessment of NAFLD. Our
study addresses this unmet need. The LITMUS Imaging
Study is a prospectively recruited multi-centre cohort
study evaluating magnetic resonance imaging and elastography, and ultrasound elastography against liver histology as the reference standard. Imaging biomarkers and biopsy are acquired within a 100-day window. The
study employs standardised processes for imaging data collection and analysis as well as a real time central monitoring and quality control process for all the data submitted for analysis. It is anticipated that the high-quality data generated from this
study will underpin changes in clinical practice for the benefit of people with NAFLD.
Study Registration: clinicaltrials.gov: NCT05479721.