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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05359497
Collaborator
Perspectum (Industry)
50
Enrollment
1
Arm
19
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Liver Multiscan sequences baseline
  • Device: MRCP+ analysis baseline
  • Device: Liver Multiscan analysis baseline
  • Diagnostic Test: MRI liver with MRCP
  • Diagnostic Test: Liver Multiscan sequences follow-up
  • Device: MRCP+ analysis follow up
  • Device: Liver Multiscan analysis follow up
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, observational studyProspective, observational study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Additional sequences and extra MRI

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.

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.
Other Names:
  • LMS

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures [1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP]

      Decrease in total biliary volume (in ml, measured by MRCP+) and decrease in cT1 (in ms, measured by LiverMultiscan), which will be assessed by performing paired t-tests.

    Secondary Outcome Measures

    1. Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification [1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP]

      The outcomes of both MRCP+ and Liver Multiscan of the baseline MRI will be compared with the modified amsterdam cholangiographic classification and the correlation coefficient will be calculated. The cholangiographic classification uses age and classification of the intrahepatic and extrahepatic biliary ducts to determine a prognostic score. This score ranges from 0-40, in which a score of 40 reflects the worst prognosis with e.g. a 1-year survival of 29% and 5-year survival of 3.3%, while zero points reflect a 1-year or 5-year survival of 98% or 94%, respectively.

    2. Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors. [1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP]

      MRCP+ given dilatations and strictures are compared with the in-depth assessment of strictures and dilatations of the MRCP, by two independent radiologists, specialized in MRCP. The correlation coefficient will be calculated.

    3. Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures. [1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP]

      MRCP+ given strictures with increased liver multiscan values are compared with the assessment (by the hand of the classic definition) of strictures found on MRCP images. The assessment is performed by two independent radiologists, specialized in MRCP. The correlation coefficient will be calculated.

    4. Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC [1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP]

      MRI baseline and follow-up will be assessed for dominant strictures to determine the reproducibility (capability to detect dominant strictures on both baseline and follow-up MRI) of dominant strictures that were not actively treated (dilated) with the invasive ERC. The assessment is performed by two independent radiologists, specialized in MRCP.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Cyriel Ponsioen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    C.Y. Ponsioen, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05359497
    Other Study ID Numbers:
    • MALD study
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by C.Y. Ponsioen, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Liver Multiscan
    MRCP+
    Additional relevant MeSH terms:
    Cholangitis
    Cholangitis, Sclerosing
    Liver Extracts

    Study Results

    No Results Posted as of May 4, 2022