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
Abstract
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.
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BibTeX
@article{pavlides2026liver,
title = {{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}},
author = {Michael Pavlides and Ferenc Mózes and Salma Akhtar and Kristy Wonders and Jeremy Cobbold and Elizabeth Tunnicliffe and Michael Allison and Edmund Godfrey and Guruprasad Aithal and Susan Francis and Manuel Romero-Gomez and Javier Castell and Isabel Fernandez-Lizaranzu and Rocio Aller and Rebeca Sigüenza González and Salvador Agustin and Juan Pericàs and Jerome Boursier and Christophe Aube and Vlad Ratziu and Mathilde Wagner and Salvatore Petta and Michela Antonucci and Elisabetta Bugianesi and Riccardo Faletti and Luca Miele and Andreas Geier and Jörn Schattenberg and Emrich Tilman and Mattias Ekstedt and Peter Lundberg and Annalisa Berzigotti and Adrian Huber and George Papatheodoridis and Hannele Yki-Järvinen and Kimmo Porthan and Moritz Jörg Schneider and Paul Hockings and Elizabeth Shumbayawonda and Rajarshi Banerjee and Kay Pepin and Mike Kalutkiewicz and Richard Ehman and Aldo Trylesinksi and Harvey Coxson and Miljen Martic and Carla Yunis and Theresa Tuthill and Patrick Bossuyt and Quentin Anstee and Stefan Neubauer and Stephen Harrison},
journal = {Contemporary Clinical Trials},
year = {2026},
month = oct,
doi = {10.1016/j.cct.2023.107352},
url = {https://hal.science/hal-05840404v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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
AU - Michael Pavlides
AU - Ferenc Mózes
AU - Salma Akhtar
AU - Kristy Wonders
AU - Jeremy Cobbold
AU - Elizabeth Tunnicliffe
AU - Michael Allison
AU - Edmund Godfrey
AU - Guruprasad Aithal
AU - Susan Francis
AU - Manuel Romero-Gomez
AU - Javier Castell
AU - Isabel Fernandez-Lizaranzu
AU - Rocio Aller
AU - Rebeca Sigüenza González
AU - Salvador Agustin
AU - Juan Pericàs
AU - Jerome Boursier
AU - Christophe Aube
AU - Vlad Ratziu
AU - Mathilde Wagner
AU - Salvatore Petta
AU - Michela Antonucci
AU - Elisabetta Bugianesi
AU - Riccardo Faletti
AU - Luca Miele
AU - Andreas Geier
AU - Jörn Schattenberg
AU - Emrich Tilman
AU - Mattias Ekstedt
AU - Peter Lundberg
AU - Annalisa Berzigotti
AU - Adrian Huber
AU - George Papatheodoridis
AU - Hannele Yki-Järvinen
AU - Kimmo Porthan
AU - Moritz Jörg Schneider
AU - Paul Hockings
AU - Elizabeth Shumbayawonda
AU - Rajarshi Banerjee
AU - Kay Pepin
AU - Mike Kalutkiewicz
AU - Richard Ehman
AU - Aldo Trylesinksi
AU - Harvey Coxson
AU - Miljen Martic
AU - Carla Yunis
AU - Theresa Tuthill
AU - Patrick Bossuyt
AU - Quentin Anstee
AU - Stefan Neubauer
AU - Stephen Harrison
PY - 2026
DA - 2026/10/27
JO - Contemporary Clinical Trials
DO - 10.1016/j.cct.2023.107352
UR - https://hal.science/hal-05840404v1
AB - 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.
SN - 1551-7144
ER -