Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 18
- 主要终点
- Diagnostic accuracy of imaging biomarkers for severity of liver fibrosis on histology as reference standard
研究概览
简要总结
The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.
详细描述
The LITMUS Imaging study is a non-interventional, observational study conducted in parallel to the European NAFLD Registry (NCT04442334), collecting cross-sectional and longitudinal ultrasound elastography and magnetic resonance elastography and imaging data. The LITMUS Imaging study recruits patients with NAFLD who are having a clinically indicated liver biopsy and are already participating in the European NAFLD Registry. Patients in the LITMUS Imaging study have additional imaging assessments at baseline (within 100 days of baseline liver biopsy) and 2 years after baseline (no follow-up biopsy necessary). Imaging assessments include point shear wave elastography, 2D shear wave elastography, MRI scans (Liver Multiscan, deMILI, diffusion weighted imaging, proton density fat fraction, T1 mapping) and MR elastography. Link-anonymised magnetic resonance data are uploaded to a central online portal and analysed centrally by 4 imaging core labs provided by Perspectum (Liver Multiscan), Antaros Medical (MR elastography and DWI), Resoundant (vendor specific PDFF) and University of Seville (deMILI).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recruited to the European NAFLD Registry
- •Patient had a liver biopsy less than 3 months prior to enrolment into the study or is having a liver biopsy in less than 3 months' time for the assessment of NAFLD.
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •Patients that do not speak the language in which the patient information is written will be excluded. Due to the nature of the study, being able to read the information about the study or access to a relevant interpreter is a necessary criterion for participant's safety in regards to MR scanning.
- •Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures)
- •Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. ferrous metal implants/fragments, implantable cardiac defibrillator or permanent pacemaker, metal clips following neurosurgery, pregnancy, other condition that would make MR scanning unsafe in the opinion of the scanner operator)
结局指标
主要结局
Diagnostic accuracy of imaging biomarkers for severity of liver fibrosis on histology as reference standard
时间窗: baseline
sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve
次要结局
- To evaluate reproducibility and observer dependent variability in reporting of liver imaging biomarkers(evaluation of biomarkers within 30 days)
- Diagnostic accuracy of imaging biomarkers for diagnosis of NASH on histology as reference standard(baseline)
- To identify physiological factors that confound the performance of imaging biomarkers for the assessment of fibrosis(baseline)
- Diagnostic accuracy of imaging biomarkers for histologically assessed fat and iron deposition as reference standard(baseline)
- To study the natural history of NAFLD and how this may impact prognosis(evaluation of biomarkers at baseline and after 2 years)