BISECT (Biliary dISease hEalth eConomic sTudy).
Research type
Research Study
Full title
Quantitative Magnetic Resonance Imaging in Biliary Disease: Health Economics Study
IRAS ID
270092
Contact name
Palak Trivedi
Contact email
Sponsor organisation
Perspectum Diagnostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 29 days
Research summary
PSC is an autoimmune disease of the biliary tree that leads to a chronic inflammatory cholestatic condition and can be life threatening.There is no effective test to monitor and diagnose the disease, and liver transplantation is the only life-extending intervention; PSC accounts for 15% of all European liver transplantations.
At present, PSC diagnosis and monitoring requires magnetic resonance cholangiopancreatography (MRCP)however the results are not consistent and each radiologist might have a different interpretation of the results. Standard MRCP can not help clinicians with a quantitative assessment of the health of the biliary tree and therefore clinicians can not monitor their patients effectively.
Enhanced MRCP, MRCP+, enables direct quantitative measurement of the biliary tree, by enhancing MRCP images and yielding advanced quantitative biliary measures.Enhanced MRCP therefore addresses both European and US Liver society (EASL and AASLD) concerns that early changes of PSC are missed by MRCP.
This project will be carried out for one year investigating 40 participants with PSC, who will be recruited at the University Hospitals Birmingham Queen Elizabeth Hospital. Participants will undergo multi-parametric MRI with LiverMultiScan (LMS) and enhanced MRCP scans in addition to their usual standard of care. The MRCP+ and LMS reports, generated by Perspectum Diagnostics, will be sent to the consultant who will evaluate if the result of scans could add value to the standard of care. Within 6 months after MRI scan participants will have a Fibroscan as part of their standard of care.
This project aims to validate an imaging platform, enhanced MRCP (MRCP+), to improve the standard of care for patients by generating the real-world evidence needed to support clinical adoption, in addition to heath economic data to evaluate the cost-effectiveness and impact on the clinical care pathway.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0326
Date of REC Opinion
22 Jan 2020
REC opinion
Further Information Favourable Opinion