MoBILISE v1.0
Research type
Research Study
Full title
Multiparametric Magnetic Resonance Imaging (MRI) of Biliary Diseases
IRAS ID
241312
Contact name
Emmanuel Selvaraj
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
15 years, 0 months, 1 days
Research summary
Magnetic resonance imaging (MRI) remains the non-invasive imaging modality of choice in the assessment of patients with biliary diseases. MRI acquisition and three dimensional (3D) reconstruction protocols vary across centres. There is no standard model for interpreting MRI data and assessment is limited to subjective interpretation. There is an unmet need for developing imaging techniques that can provide objective measurements to enable earlier detection of disease, determination of disease stage, treatment response and prognosis in biliary diseases.
This study will investigate whether, measurements obtained from MRI techniques of the biliary tree and liver using two standardised image processing software packages (MRCP+ and LiverMultiscan™), can predict clinical endpoints. We will also be assessing if they can be used to diagnose biliary diseases, quantify liver scarring and monitor disease progression. There are five participant groups in this study: group 1 (primary sclerosing cholangitis - PSC), group 2 (immunoglobulin-4-related sclerosing cholangitis - IgG4-SC), group 3 (benign/malignant stricture), group 4 (other biliary diseases) and group 5 (healthy volunteers). The study will involve both retrospective and prospective data collection. We will examine the association between MRI measurements and important clinical endpoints such mortality, liver-related and biliary-related events. We will also explore its association with patient demographics, disease and treatment history, laboratory tests, liver stiffness measurements (Fibroscan®), conventional MRI features and data from any previous tissue sampling. Healthy volunteers will be recruited to establish normal values for comparison.
The study is for 15 years and is funded by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre. We hope the study will contribute towards improving the assessment and monitoring of biliary diseases as well as better rationalise the need for invasive biliary interventions.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0367
Date of REC Opinion
31 Jul 2018
REC opinion
Further Information Favourable Opinion