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
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:134 |
|---|---|
| Enthalten in: |
Contemporary clinical trials - 134(2023) vom: 05. Nov., Seite 107352 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 27.11.2023 Date Revised 27.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT05479721 Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.cct.2023.107352 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362958297 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362958297 | ||
| 003 | DE-627 | ||
| 005 | 20231226092327.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.cct.2023.107352 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1209.xml |
| 035 | |a (DE-627)NLM362958297 | ||
| 035 | |a (NLM)37802221 | ||
| 035 | |a (PII)S1551-7144(23)00275-6 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Pavlides, Michael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Liver Investigation |b 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 |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.11.2023 | ||
| 500 | |a Date Revised 27.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05479721 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a 2D shear wave elastography | |
| 650 | 4 | |a 2DSWE | |
| 650 | 4 | |a DeMILI | |
| 650 | 4 | |a Diffusion weighted imaging | |
| 650 | 4 | |a Fibro-MRI | |
| 650 | 4 | |a Iron corrected T1 | |
| 650 | 4 | |a Liver Multiscan | |
| 650 | 4 | |a Magnetic resonance elastography | |
| 650 | 4 | |a NASH-MRI | |
| 650 | 4 | |a PDFF | |
| 650 | 4 | |a Proton density fat fraction | |
| 650 | 4 | |a R2* | |
| 650 | 4 | |a T1 mapping | |
| 650 | 4 | |a T2* | |
| 650 | 4 | |a VCTE | |
| 650 | 4 | |a liver stiffness | |
| 650 | 4 | |a pSWE | |
| 650 | 4 | |a point shear wave elastography | |
| 650 | 4 | |a ultrasound elastography | |
| 650 | 4 | |a vibration controlled transient elastography | |
| 650 | 7 | |a Biomarkers |2 NLM | |
| 700 | 1 | |a Mózes, Ferenc E |e verfasserin |4 aut | |
| 700 | 1 | |a Akhtar, Salma |e verfasserin |4 aut | |
| 700 | 1 | |a Wonders, Kristy |e verfasserin |4 aut | |
| 700 | 1 | |a Cobbold, Jeremy |e verfasserin |4 aut | |
| 700 | 1 | |a Tunnicliffe, Elizabeth M |e verfasserin |4 aut | |
| 700 | 1 | |a Allison, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Godfrey, Edmund M |e verfasserin |4 aut | |
| 700 | 1 | |a Aithal, Guruprasad P |e verfasserin |4 aut | |
| 700 | 1 | |a Francis, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Romero-Gomez, Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Castell, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Fernandez-Lizaranzu, Isabel |e verfasserin |4 aut | |
| 700 | 1 | |a Aller, Rocio |e verfasserin |4 aut | |
| 700 | 1 | |a González, Rebeca Sigüenza |e verfasserin |4 aut | |
| 700 | 1 | |a Agustin, Salvador |e verfasserin |4 aut | |
| 700 | 1 | |a Pericàs, Juan M |e verfasserin |4 aut | |
| 700 | 1 | |a Boursier, Jerome |e verfasserin |4 aut | |
| 700 | 1 | |a Aube, Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Ratziu, Vlad |e verfasserin |4 aut | |
| 700 | 1 | |a Wagner, Mathilde |e verfasserin |4 aut | |
| 700 | 1 | |a Petta, Salvatore |e verfasserin |4 aut | |
| 700 | 1 | |a Antonucci, Michela |e verfasserin |4 aut | |
| 700 | 1 | |a Bugianesi, Elisabetta |e verfasserin |4 aut | |
| 700 | 1 | |a Faletti, Riccardo |e verfasserin |4 aut | |
| 700 | 1 | |a Miele, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Geier, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Schattenberg, Jörn M |e verfasserin |4 aut | |
| 700 | 1 | |a Tilman, Emrich |e verfasserin |4 aut | |
| 700 | 1 | |a Ekstedt, Mattias |e verfasserin |4 aut | |
| 700 | 1 | |a Lundberg, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Berzigotti, Annalisa |e verfasserin |4 aut | |
| 700 | 1 | |a Huber, Adrian T |e verfasserin |4 aut | |
| 700 | 1 | |a Papatheodoridis, George |e verfasserin |4 aut | |
| 700 | 1 | |a Yki-Järvinen, Hannele |e verfasserin |4 aut | |
| 700 | 1 | |a Porthan, Kimmo |e verfasserin |4 aut | |
| 700 | 1 | |a Schneider, Moritz Jörg |e verfasserin |4 aut | |
| 700 | 1 | |a Hockings, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Shumbayawonda, Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Banerjee, Rajarshi |e verfasserin |4 aut | |
| 700 | 1 | |a Pepin, Kay |e verfasserin |4 aut | |
| 700 | 1 | |a Kalutkiewicz, Mike |e verfasserin |4 aut | |
| 700 | 1 | |a Ehman, Richard L |e verfasserin |4 aut | |
| 700 | 1 | |a Trylesinksi, Aldo |e verfasserin |4 aut | |
| 700 | 1 | |a Coxson, Harvey O |e verfasserin |4 aut | |
| 700 | 0 | |a LITMUS Consortium Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Martic, Miljen |e verfasserin |4 aut | |
| 700 | 1 | |a Yunis, Carla |e verfasserin |4 aut | |
| 700 | 1 | |a Tuthill, Theresa |e verfasserin |4 aut | |
| 700 | 1 | |a Bossuyt, Patrick M |e verfasserin |4 aut | |
| 700 | 1 | |a Anstee, Quentin M |e verfasserin |4 aut | |
| 700 | 1 | |a Neubauer, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Harrison, Stephen |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Contemporary clinical trials |d 2005 |g 134(2023) vom: 05. Nov., Seite 107352 |w (DE-627)NLM154869031 |x 1559-2030 |7 nnns |
| 773 | 1 | 8 | |g volume:134 |g year:2023 |g day:05 |g month:11 |g pages:107352 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.cct.2023.107352 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 134 |j 2023 |b 05 |c 11 |h 107352 | ||