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

• Published in: Contemporary clinical trials Vol. 134
• Main Authors: Pavlides, Michael, Mozes, 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, Gonzalez, Rebeca Siguenza, Agustin, Salvador, Pericas, Juan M., Boursier, Jerome, Aube, Christophe, Ratziu, Vlad, Wagner, Mathilde, Petta, Salvatore, Antonucci, Michela, Bugianesi, Elisabetta, Faletti, Riccardo, Miele, Luca, Geier, Andreas, Schattenberg, Jorn M., Tilman, Emrich, Ekstedt, Mattias, Lundberg, Peter, Berzigotti, Annalisa, Huber, Adrian T., Papatheodoridis, George, Yki-Jarvinen, Hannele, Porthan, Kimmo, Schneider, Moritz Jorg, Hockings, Paul, Shumbayawonda, Elizabeth, Banerjee, Rajarshi, Pepin, Kay, Kalutkiewicz, Mike, Ehman, Richard L., Coxson, Harvey O., LITMUS Consortium Investigators, Martic, Miljen, Yunis, Carla, Tuthill, Theresa, Bossuyt, Patrick M., Anstee, Quentin M., Neubauer, Stefan, Harrison, Stephen
• Format: Journal Article
• Language: English
• Published: 2023
• Subjects: R2; NASH-MRI; Iron corrected T1; pSWE; DeMILI; 2D shear wave elastography; T1 mapping; 2DSWE; PDFF; vibration controlled transient elastography; Magnetic resonance elastography; point shear wave elastography; Proton density fat fraction; VCTE; Liver Multiscan; liver stiffness; Diffusion weighted imaging; Fibro-MRI; ultrasound elastography; T2
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2023.107352

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