Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol

Contemp Clin Trials. 2023 Nov:134:107352. doi: 10.1016/j.cct.2023.107352. Epub 2023 Oct 4.


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: NCT05479721.

Keywords: 2D shear wave elastography; 2DSWE; DeMILI; Diffusion weighted imaging; Fibro-MRI; Iron corrected T1; Liver Multiscan; Magnetic resonance elastography; NASH-MRI; PDFF; Proton density fat fraction; R2*; T1 mapping; T2*; VCTE; liver stiffness; pSWE; point shear wave elastography; ultrasound elastography; vibration controlled transient elastography.

MeSH terms

  • Biomarkers
  • Cohort Studies
  • Humans
  • Liver / diagnostic imaging
  • Liver / pathology
  • Liver Cirrhosis / diagnostic imaging
  • Liver Cirrhosis / pathology
  • Magnetic Resonance Imaging / methods
  • Non-alcoholic Fatty Liver Disease* / diagnostic imaging
  • Non-alcoholic Fatty Liver Disease* / pathology


  • Biomarkers

Associated data