NCT05359497

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• PSC
• MRI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liver Multiscan sequences baseline	Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.
DEVICE	MRCP+ analysis baseline	Post processing tool (Software) for quantifying MRCP images after MRCP is performed. Patient involvement is not necessary during this procedure.
DEVICE	Liver Multiscan analysis baseline	Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences at baseline are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.
DIAGNOSTIC_TEST	MRI liver with MRCP	An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol
DIAGNOSTIC_TEST	Liver Multiscan sequences follow-up	Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.
DEVICE	MRCP+ analysis follow up	Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.
DEVICE	Liver Multiscan analysis follow up	Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences from the follow up scan are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-12-01
• First posted: 2022-05-04
• Last updated: 2022-05-04

Regulatory

• FDA-regulated device study