NAFLD Clinical Trial - LITMUS Imaging Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Fibrosis, Liver
Liver Cirrhosis
NAFLD
NASH
NASH - Nonalcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Steatosis of Liver

Clinical Trial Details

NCT number	NCT05479721
Study type	Observational
Source	University of Oxford
Contact	Michael Pavlides, MBBS, DPhil
Phone	+441865234577
Email	michael.pavlides@cardiov.ox.ac.uk
Status	Recruiting
Phase
Start date	September 4, 2019
Completion date	October 31, 2022

View Details

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