LITMUS Imaging Study

Last updated: April 11, 2025
Sponsor: University of Oxford
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Liver Disease

Hepatic Fibrosis

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT05479721
IRAS ID 250344
18/LO/1953
  • Ages 18-100
  • All Genders

Study Summary

The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Recruited to the European NAFLD Registry

  2. Patient had a liver biopsy less than 3 months prior to enrolment into the study oris having a liver biopsy in less than 3 months' time for the assessment of NAFLD.

  3. Participant is willing and able to give informed consent for participation in thestudy.

Exclusion

Exclusion Criteria:

  1. Patients that do not speak the language in which the patient information is writtenwill be excluded. Due to the nature of the study, being able to read the informationabout the study or access to a relevant interpreter is a necessary criterion forparticipant's safety in regards to MR scanning.

  2. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to complywith the study procedures)

  3. Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. ferrous metalimplants/fragments, implantable cardiac defibrillator or permanent pacemaker, metalclips following neurosurgery, pregnancy, other condition that would make MR scanningunsafe in the opinion of the scanner operator)

Study Design

Total Participants: 450
Study Start date:
September 04, 2019
Estimated Completion Date:
October 31, 2025

Study Description

The LITMUS Imaging study is a non-interventional, observational study conducted in parallel to the European NAFLD Registry (NCT04442334), collecting cross-sectional and longitudinal ultrasound elastography and magnetic resonance elastography and imaging data. The LITMUS Imaging study recruits patients with NAFLD who are having a clinically indicated liver biopsy and are already participating in the European NAFLD Registry. Patients in the LITMUS Imaging study have additional imaging assessments at baseline (within 100 days of baseline liver biopsy) and 2 years after baseline (no follow-up biopsy necessary). Imaging assessments include point shear wave elastography, 2D shear wave elastography, MRI scans (Liver Multiscan, deMILI, diffusion weighted imaging, proton density fat fraction, T1 mapping) and MR elastography. Link-anonymised magnetic resonance data are uploaded to a central online portal and analysed centrally by 4 imaging core labs provided by Perspectum (Liver Multiscan), Antaros Medical (MR elastography and DWI), Resoundant (vendor specific PDFF) and University of Seville (deMILI).

Connect with a study center

  • Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • Le Centre de Recherche Clinique (CRC) du CHU d'Angers

    Angers,
    France

    Site Not Available

  • Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière

    Paris,
    France

    Site Not Available

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz

    Mainz,
    Germany

    Site Not Available

  • Universitätsklinikums Würzburg

    Würzburg,
    Germany

    Site Not Available

  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • Università di Palermo

    Palermo,
    Italy

    Site Not Available

  • Department of Medical Sciences University of Torino

    Torino,
    Italy

    Site Not Available

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Site Not Available

  • Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital

    Sevilla,
    Spain

    Site Not Available

  • HU Clínico de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • Linköping University Hospital

    Linköping,
    Sweden

    Site Not Available

  • Inselspital, University Hospital

    Bern,
    Switzerland

    Site Not Available

  • Addenbrookes Hospital

    Cambridge,
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Queens Medical Centre

    Nottingham,
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Pinnacle Clinical Research

    San Antonio, Texas 78201
    United States

    Site Not Available

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