Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis (CATCH-IT)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Not yet enrolling

Conditions: Primary Sclerosing Cholangitis

Treatments: Device: Liver Multiscan analysis; Device: MRCP+; Device: Liver Multiscan sequences

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05462093

CATCH-IT

Details and patient eligibility

About

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years.

Diagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy.

Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. Also, the lack of surrogate endpoints impedes performing clinical research. Recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by MRC. These tools called MRCP+ (quantitative magnetic resonance cholangiopancreatography +) and LiverMultiscan (LMS) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, several features must be tested before the utility of this tools in clinical patient care can be concluded. Therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual MRI's.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established PSC diagnosis according to the IPSCSG definitions
• Age ≥ 18
• Able to give informed consent

Exclusion criteria

• Post LTx
• Known allergy for MRI contrast agents, implants non-compatible with MRI or extreme claustrophobia causing discontinuation of MRI studies.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Additional sequences with MRCP+ and LiverMultiscan

Other group

Description:

PSC patients that undergo annual, standard care, MRI of the liver and MRCP will undergo additional Liver Multiscan sequences, taking approximately 15 minutes. After the MRI is performed, post-processing analysis named MRCP+ and LiverMultiscan will be performed without patient involvement.

Treatment:

Device: Liver Multiscan sequences

Device: MRCP+

Device: Liver Multiscan analysis