Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

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

Status

Unknown

Conditions

MRI

PSC

Treatments

Device: MRCP+ analysis baseline

Device: Liver Multiscan analysis follow up

Device: MRCP+ analysis follow up

Diagnostic Test: Liver Multiscan sequences follow-up

Diagnostic Test: MRI liver with MRCP

Device: Liver Multiscan analysis baseline

Diagnostic Test: Liver Multiscan sequences baseline

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05359497

MALD study

Details and patient eligibility

About

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease. 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. Novel imaging techniques called MRCP+ and Liver Multiscan (LMS) hold the prospect of adequate depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, these features must be tested first.

The purpose of this study is to assess the (i) ability of MRCP+ to detect change in biliary volume, (ii) reproducibility of MRCP+ and LMS, and (iii) correlation of MRCP+ with ERC findings as gold standard.

Full description

After informed consent, patients will undergo standard care with blood tests and MRI/MRCP. While performing the MRI, additional sequences called LMS are performed. Thereafter, an ERCP will be performed. Approximately 8 weeks after ERCP, another MRI/MRCP and LMS will be performed. Also, blood tests will be performed and a clinician will evaluate the clinical condition and complaints of patients

Images will be coded and analysed by Perspectum to retrieve MRCP+ and LMS results.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Established diagnosis according to the IPSCSG Definitions (22)
Age ≥ 18
Able to give informed consent
Clinically suspicious for a dominant stricture

Exclusion criteria

insufficient image quality
known allergy for MRI contrast agents

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Additional sequences and extra MRI

Other group

Description:

PSC patients, suspected for having a dominant stenosis, that undergo additional LMS sequences next to standard care MRI prior to ERCP and an additional MRI/MRCP with additional LMS sequences 8 weeks after ERCP. MRI images will be analysed by the post-processing tool called MRCP+ and Liver Multiscan, which are performed after the MRI is performed.