LITMUS Imaging Study

Running, not enrolling

Conditions studied: NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver

In brief

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.

Key facts

Study ID

NCT05479721

Run by

University of Oxford

People needed

450

Starts

2019-09-04

Expected to finish

2025-10-31

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recruited to the European NAFLD Registry
• Patient had a liver biopsy less than 3 months prior to enrolment into the study or is having a liver biopsy in less than 3 months' time for the assessment of NAFLD.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if…

• Patients that do not speak the language in which the patient information is written will be excluded. Due to the nature of the study, being able to read the information about the study or access to a relevant interpreter is a necessary criterion for participant's safety in regards to MR scanning.
• 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 comply with the study procedures)
• Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. ferrous metal implants/fragments, implantable cardiac defibrillator or permanent pacemaker, metal clips following neurosurgery, pregnancy, other condition that would make MR scanning unsafe in the opinion of the scanner operator)

Where it is running

• Pinnacle Clinical Research — San Antonio, Texas, United States
• Helsinki University Hospital — Helsinki, Finland
• Le Centre de Recherche Clinique (CRC) du CHU d'Angers — Angers, France
• Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière — Paris, France
• UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz — Mainz, Germany
• Universitätsklinikums Würzburg — Würzburg, Germany
• Laiko General Hospital of Athens — Athens, Greece
• Università di Palermo — Palermo, Italy
• Department of Medical Sciences University of Torino — Torino, Italy
• Vall d'Hebron University Hospital — Barcelona, Spain
• Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital — Seville, Spain
• HU Clínico de Valladolid — Valladolid, Spain
• Linköping University Hospital — Linköping, Sweden
• Inselspital, University Hospital — Bern, Switzerland
• Addenbrookes Hospital — Cambridge, United Kingdom
• The Newcastle Upon Tyne Hospitals Nhs Foundation Trust — Newcastle upon Tyne, United Kingdom
• Queens Medical Centre — Nottingham, United Kingdom
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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