An observational study in Primary Sclerosing Cholangitis and PSC, sponsored by Perspectum. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Perspectum · Observational
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.
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.
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
Browse Cholangitis, Sclerosing studies →Perspectum is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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40 adult participants will be recruited who are over the age of 18 and are attending a hepatology appointment at UHB and are either being investigated for PSC or have confirmed PSC.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary sclerosing cholangitis, as defined by EASL and AASLD guidelines.
Device: Quantitative Multi parametric MRI and enhanced MRCP
Patients will have quantitative MRI and enhanced MRCP on addition to their standard of care
quantitative measurements using Enhance MRCP (MRCP+) and Physicians' decision making
To assess the effect of quantitative data from MRCP+ results on a physicians' diagnosis and/or plans for care of patients with suspected or confirmed PSC compared with usual standard of care.
Time frame: 8 months
Cost effectiveness of using enhanced MRCP (MRCP+) for diagnosis and monitoring of PSC patients
To quantify the potential reduction in patient management costs by reducing unnecessary appointments in secondary care by using MRCP+ technology quantitative reports in diagnosis and monitoring of PSC patients more accurately.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Mar 2021, 3 months.
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This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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