Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04015310 |
Other study ID # |
EC-156 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 21, 2020 |
Est. completion date |
March 31, 2021 |
Study information
Verified date |
July 2021 |
Source |
Perspectum |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This is a health economic study on using quantitative magnetic resonance imaging in biliary
disease. It is an observational study aiming to recruit 40 patients with Primary Sclerosing
Cholangitis (PSC) in 12 months. The aim of the study is to assess the effect of result of
enhanced Magnetic Resonance Cholangiopancreatography (MRCP+) on the physicians' diagnosis
and/or plans for patients with suspected or confirmed PSC, compared with usual standard of
care. This study also aims to identify the cost-effectiveness of adding MRCP+ to the standard
care pathway.
Description:
Primary sclerosing cholangitis (PSC) is the greatest unmet need in modern liver medicine.
There continue to be no direct bio-markers for the diagnosis and monitoring of biliary
diseases such as PSC, constituting a major barrier to drug development and to poor patient
outcomes. This project aims to validate an imaging platform, enhanced Magnetic Resonance
Cholangiopancreatography, MRCP+, to improve the standard of care for patients by generating
the real-world evidence needed to support clinical adoption.
Biliary diseases significantly increase the likelihood of developing sclerosing cholangitis
(SC), causing major morbidity and mortality. Sclerosing cholangitis, a chronic inflammatory
cholestatic condition, is exemplified by the primary idiopathic autoimmune condition PSC. In
the absence of effective therapies, hindered by a lack of measurable trial endpoints
(bio-markers), liver transplantation is the only life-extending intervention, with PSC
accounting for 15% of all European liver transplantations. Furthermore, biliary complications
occur in 5-32% of all liver transplantations. MRCP+ has the potential to significantly
improve the outlook for patients.
At present, diagnosis requires cholangiopancreatography, either magnetic resonance (MRCP) or
endoscopic retrograde (ERCP). The current standard ERCP is expensive, invasive, and
associated with a high risk of morbidity. MRCP is less invasive and cheaper. However, both
result in inconsistent qualitative interpretations. MRCP+ is the first device to enable
direct quantitative measurement of biliary disease and addresses both European and US Liver
society (EASL and AASLD) concerns that early changes of PSC are missed by MRCP, necessitating
adequate visualisation and quantitative assessment.
MRCP+ both enhances MRCP images and yields advanced quantitative biliary measures. Initial
experience shows significant clinical potential. This project will provide substantive
evidence for clinical adoption via a real-world study including heath economics to evaluate
the cost-effectiveness and impact on the clinical care pathway.
To achieve this, 40 patients were recruited from the University Hospitals Birmingham (UHB)
who are attending the centre for either a review or diagnosis of PSC. The patients will
follow their usual care pathway, being seen by the consultant who will document their care
plan. Following this appointment, and their consent, they will be asked to undergo a
non-invasive, pain-free Magnetic Resonance Imaging (MRI) scan. MRCP+ reports generated from
these scans will be returned to the consultant who will review the documented standard care
treatment plan and ascertain whether any amendments would have been made in light of these
further quantitative metrics gained from MRI.
The study team alongside the Oxford Academic Health Science Network (OAHSN), will use the
clinical data generated by the 40 patients and create a health economic model, which can be
used to generate a business case for adoption, an impact case study for dissemination across
the network of 15 centres in the Academic Health Science Networks (AHSN) and contribute to a
submission for Human Tissue Authority (HTA) as part of the evidence required to gain health
technology adoption via the National Institute for Health and Care Excellence (NICE) Medical
Technologies Evaluation Programme (MTEP) route.