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

Pavlides, Michael; Mózes, Ferenc E; Akhtar, Salma; Wonders, Kristy; Cobbold, Jeremy; Tunnicliffe, Elizabeth M; Allison, Michael; Godfrey, Edmund M; Aithal, Guruprasad P; Francis, Susan; Romero-Gomez, Manuel; Castell, Javier; Fernandez-Lizaranzu, Isabel; Aller, Rocio; Sigüenza González, Rebeca; Agustin, Salvador; Pericàs, Juan M; Boursier, Jerome; Aube, Christophe; Ratziu, Vlad; Wagner, Mathilde; Petta, Salvatore; Antonucci, Michela; Bugianesi, Elisabetta; Faletti, Riccardo; Miele, Luca; Geier, Andreas; Schattenberg, Jörn M; Tilman, Emrich; Ekstedt, Mattias; Lundberg, Peter; Berzigotti, Annalisa; Huber, Adrian T; Papatheodoridis, George; Yki-Järvinen, Hannele; Porthan, Kimmo; Schneider, Moritz Jörg; Hockings, Paul; Shumbayawonda, Elizabeth; Banerjee, Rajarshi; Pepin, Kay; Kalutkiewicz, Mike; Ehman, Richard L; Trylesinksi, Aldo; Coxson, Harvey O; LITMUS Consortium Investigators, The; Martic, Miljen; Yunis, Carla; Tuthill, Theresa; Bossuyt, Patrick M; Anstee, Quentin M; Neubauer, Stefan;...

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

Citation

Pavlides, M., Mózes, F. E., Akhtar, S., Wonders, K., Cobbold, J., Tunnicliffe, E. M., Allison, M., Godfrey, E. M., Aithal, G. P., Francis, S., Romero-Gomez, M., Castell, J., Fernandez-Lizaranzu, I., Aller, R., Sigüenza González, R., Agustin, S., Pericàs, J. M., Boursier, J., Aube, C., Ratziu, V., …Harrison, S. (2023). 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. Contemporary Clinical Trials, 134, Article 107352. https://doi.org/10.1016/j.cct.2023.107352

• Journal Article Type: Article
• Acceptance Date: Oct 1, 2023
• Online Publication Date: Oct 4, 2023
• Publication Date: 2023-11
• Deposit Date: Oct 3, 2023
• Publicly Available Date: Oct 19, 2023
• Journal: Contemporary Clinical Trials
• Print ISSN: 1551-7144
• Electronic ISSN: 1559-2030
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 134
• Article Number: 107352
• DOI: https://doi.org/10.1016/j.cct.2023.107352
• Keywords: Liver Multiscan; Iron corrected T1; T2*; Magnetic resonance elastography; Diffusion weighted imaging; T1 mapping; Proton density fat fraction; PDFF; R2*; DeMILI; Fibro-MRI; NASH-MRI; ultrasound elastography; liver stiffness; 2D shear wave elastography; 2DSWE; point shear wave elastography; pSWE; vibration controlled; transient elastography; VCTE
• Public URL: https://nottingham-repository.worktribe.com/output/25672870
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S1551714423002756?via%3Dihub
• Additional Information: This article is maintained by: Elsevier; Article 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; Journal Title: Contemporary Clinical Trials; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.cct.2023.107352; Content Type: article; Copyright: © 2023 The Authors. Published by Elsevier Inc.