LITMUS Imaging Study
Research type
Research Study
Full title
Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance across the NAFLD Spectrum in a Prospectively Recruited Cohort
IRAS ID
250344
Contact name
Michael Pavlides
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 10 months, 29 days
Research summary
Non Alcoholic Fatty Liver Disease (NAFLD) is estimated to affect around 30-40% of the population. The disease can cause liver scarring and can progress to liver cirrhosis and its complications of liver failure and liver cancer. While a large number of patients have the condition, only a minority develop progressive liver disease. In current practice, diagnosis and risk stratification relies on liver biopsy, an invasive procedure limited by costs among other drawbacks. This is an area of unmet clinical need that has driven the development of non-invasive imaging tests for the assessment of patients with NAFLD. The aim of this study is to evaluate whether non-invasive imaging tests can be used for the diagnosis, monitoring and risk stratification of patients with NAFLD.
The study will recruit patients who are seen in hospitals and who are sent for liver biopsy by their doctor for the evaluation of NAFLD. Patients will be invited to have assessments with non-invasive imaging tests within 3 months of their liver biopsy. The imaging assessments will include magnetic resonance imaging (MRI) scans and ultrasound scans. The imaging assessments will be repeated after 2 years. A subset of 20 patients will have additional ultrasound and MRI scans within 1 month of their first visit in order to optimise the scanning protocols for MRI and Ultrasound.
Up to 20 healthy volunteers will be recruited to undergo study procedures if required for the calibration of MR scanners and ultrasound machines.REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/1953
Date of REC Opinion
3 Dec 2018
REC opinion
Favourable Opinion