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NCT Number: NCT05462093

Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver Multiscan sequences

Device

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

Liver Multiscan analysis

Device

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

MRCP+

Device

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

Primary outcomes

  1. Delta of cT1 in patients with PSC during follow-up

    Time frame: 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 outcomes

  1. Assesment of th mean, median and range of cT1 and MRCP+ metrics in stable PSC patients

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tim E Middelburg, MSC

CONTACT

[email protected]

+31648510414

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Perspectum

Registry information

Official study title

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

Acronym: CATCH-IT

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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