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LITMUS Imaging Study
LITMUS Imaging Study

NCT05479721

Active Not RecruitingN/A

Sponsor: University of Oxford

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

Countries: United States, Finland, France, Germany, Greece, Italy, Spain, Sweden

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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 or is 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 the study.

Exclusion Criteria:

1. 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.
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 comply with the study procedures)
3. 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)
Locations (18)
  • San Antonio, Texas, United States
  • Helsinki, Finland
  • Angers, France
  • Paris, France
  • Mainz, Germany
  • Würzburg, Germany
  • Athens, Greece
  • Palermo, Italy
  • Torino, Italy
  • Barcelona, Spain
  • Seville, Spain
  • Valladolid, Spain
  • Linköping, Sweden
  • Bern, Switzerland
  • Cambridge, United Kingdom
  • Newcastle upon Tyne, United Kingdom
  • Nottingham, United Kingdom
  • Oxford, United Kingdom