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

Primary Purpose

PSC, MRI

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Liver Multiscan sequences baseline
MRCP+ analysis baseline
Liver Multiscan analysis baseline
MRI liver with MRCP
Liver Multiscan sequences follow-up
MRCP+ analysis follow up
Liver Multiscan analysis follow up
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PSC focused on measuring Liver Multiscan, MRCP+

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Additional sequences and extra MRI

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures
    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

    Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification
    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.
    Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors.
    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.
    Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures.
    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.
    Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC
    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.

    Full Information

    First Posted
    March 23, 2022
    Last Updated
    April 29, 2022
    Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    Perspectum
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05359497
    Brief Title
    Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
    Official Title
    Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    Perspectum

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PSC, MRI
    Keywords
    Liver Multiscan, MRCP+

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, observational study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Additional sequences and extra MRI
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Liver Multiscan sequences baseline
    Intervention Description
    Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.
    Intervention Type
    Device
    Intervention Name(s)
    MRCP+ analysis baseline
    Intervention Description
    Post processing tool (Software) for quantifying MRCP images after MRCP is performed. Patient involvement is not necessary during this procedure.
    Intervention Type
    Device
    Intervention Name(s)
    Liver Multiscan analysis baseline
    Other Intervention Name(s)
    LMS
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    MRI liver with MRCP
    Intervention Description
    An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Liver Multiscan sequences follow-up
    Intervention Description
    Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.
    Intervention Type
    Device
    Intervention Name(s)
    MRCP+ analysis follow up
    Intervention Description
    Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.
    Intervention Type
    Device
    Intervention Name(s)
    Liver Multiscan analysis follow up
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures
    Description
    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.
    Time Frame
    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
    Secondary Outcome Measure Information:
    Title
    Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification
    Description
    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.
    Time Frame
    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
    Title
    Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors.
    Description
    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.
    Time Frame
    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
    Title
    Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures.
    Description
    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.
    Time Frame
    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
    Title
    Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC
    Description
    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.
    Time Frame
    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tim E Middelburg, MSc
    Phone
    +31648510414
    Email
    t.e.middelburg@amsterdamumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cyriel Ponsioen, MD PhD
    Organizational Affiliation
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After publication, the following documentation can be requested by qualified research groups: - Study protocol, statistical analysis plan and the clinical study report can be provided if a proper request is submitted. IPD will contain decoded and only essential data for the objective of this study. Data that will be available for sharing purposes will only include decoded demographic data. Furthermore, MRCP+ data that underlies the results in the publication will be available for sharing, e.g. MRCP+ metrics
    IPD Sharing Time Frame
    Until 5 years after publication
    IPD Sharing Access Criteria
    Data sharing can be requested by qualified research groups. Requests will be evaluated by the following method: The request is supposed to contain a clear objective and methodology. E.g., it must contain the objective to explore or validate the value of MRCP+ techniques. Furthermore, the study proposal could, for example, be a systematic review or meta-analysis. The request will be reviewed by a dedicated research team of the MALD-study. This research team contains the PI, PhD student, involved gastro-enterologist and radiologist and representative of Perspectum Ltd. If the request seems valid and the credibility of the requesting party is validated, data sharing agreement will be developed with the local research support team. To submit a request, contact t.e.middelburg@amsterdamumc.nl
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    Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

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