%0 Journal Article
%T 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.
%A Pavlides M
%A Mózes FE
%A Akhtar S
%A Wonders K
%A Cobbold J
%A Tunnicliffe EM
%A Allison M
%A Godfrey EM
%A Aithal GP
%A Francis S
%A Romero-Gomez M
%A Castell J
%A Fernandez-Lizaranzu I
%A Aller R
%A González RS
%A Agustin S
%A Pericàs JM
%A Boursier J
%A Aube C
%A Ratziu V
%A Wagner M
%A Petta S
%A Antonucci M
%A Bugianesi E
%A Faletti R
%A Miele L
%A Geier A
%A Schattenberg JM
%A Tilman E
%A Ekstedt M
%A Lundberg P
%A Berzigotti A
%A Huber AT
%A Papatheodoridis G
%A Yki-Järvinen H
%A Porthan K
%A Schneider MJ
%A Hockings P
%A Shumbayawonda E
%A Banerjee R
%A Pepin K
%A Kalutkiewicz M
%A Ehman RL
%A Trylesinksi A
%A Coxson HO
%A  
%A Martic M
%A Yunis C
%A Tuthill T
%A Bossuyt PM
%A Anstee QM
%A Neubauer S
%A Harrison S
%J Contemp Clin Trials
%V 134
%N 0
%D 2023 11 4
%M 37802221
%F 2.261
%R 10.1016/j.cct.2023.107352
%X 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.