Clincosm LogoSign in Get a demo

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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05462093
Collaborator
Perspectum (Industry)
200
Enrollment
1
Arm
84
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Liver Multiscan sequences
  • Device: Liver Multiscan analysis
  • Device: MRCP+
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis: the CATCH-IT Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2028
Anticipated Study Completion Date :
Jul 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Other: Additional sequences with MRCP+ and LiverMultiscan

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.

Device: Liver Multiscan sequences
Additional Liver Multiscan sequences will be performed after the MRI liver with MRCP is performed, taking approximately 15 minutes.

Device: Liver Multiscan analysis
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

    • Device: MRCP+
    Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.

    Outcome Measures

    Primary Outcome Measures

    1. Delta of cT1 in patients with PSC during follow-up [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      The delta of cT1 (in ms), measured by LiverMultiscan, which will be assessed by performing paired t-tests.

    Secondary Outcome Measures

    1. Assesment of th mean, median and range of cT1 and MRCP+ metrics in stable PSC patients [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52;]

      Mean, median and range of cT1 and MRCP+ metrics in clinically and biochemically stable patients with PSC during the period of 1 year to establish general statistics as these are unknown at current writing

    2. Variance of the delta of cT1 and MRCP+ metrics in stable patients [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Variance of the delta in cT1 and MRCP+ metrics from baseline to year 1 in clinically and biochemically stable patients

    3. Difference in cT1 in patients with or without endoscopic intervention [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Difference in mean of cT1 values in patients who needed ERCP with treatment of dominant stricture(s) in the year following LMS measurement versus those who did not need an intervention

    4. Variance in unstable patients [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Variance of the delta of cT1 and MRCP+ metrics in sequential scans in biochemically and/or clinically deteriorating patients.

    5. Correlation of cT1 and MRCP+ metrics with fibroscan and MELD [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Correlation between cT1 and MRCP+ metrics with Fibroscan and MELD-score

    6. Correlation of cT1 and MRCP+ metrics and development of dominant strictures [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Correlation between cT1 and MRCP+ metrics and development of dominant strictures

    7. Correlation of cT1 and MRCP+ metrics and incidence of CCA [1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.]

      Correlation between cT1 and MRCP+ metrics and incidence of CCA

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Cyriel Ponsioen, Prof MD PhD, Gastroenterologist and hepatologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    C.Y. Ponsioen, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05462093
    Other Study ID Numbers:
    • CATCH-IT
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 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
    Additional relevant MeSH terms:
    Cholangitis
    Cholangitis, Sclerosing
    Liver Extracts

    Study Results

    No Results Posted as of Jul 18, 2022