NCT05359497

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 23, 2022

Last Update Submit

April 29, 2022

Conditions

PSCMRI

Keywords

Liver MultiscanMRCP+

Outcome Measures

Primary Outcomes (1)

  • 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.

    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP

Secondary Outcomes (4)

  • Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification

    1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP

  • 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

  • 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

  • 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

Study Arms (1)

Additional sequences and extra MRI

OTHER

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 baselineDevice: MRCP+ analysis baselineDevice: Liver Multiscan analysis baselineDiagnostic Test: MRI liver with MRCPDiagnostic Test: Liver Multiscan sequences follow-upDevice: MRCP+ analysis follow upDevice: Liver Multiscan analysis follow up

Interventions

Liver Multiscan sequences baselineDIAGNOSTIC_TEST

Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.

Additional sequences and extra MRI
MRCP+ analysis baselineDEVICE

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

Additional sequences and extra MRI
Liver Multiscan analysis baselineDEVICE

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.

Also known as: LMS
Additional sequences and extra MRI
MRI liver with MRCPDIAGNOSTIC_TEST

An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol

Additional sequences and extra MRI
Liver Multiscan sequences follow-upDIAGNOSTIC_TEST

Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.

Additional sequences and extra MRI
MRCP+ analysis follow upDEVICE

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

Additional sequences and extra MRI
Liver Multiscan analysis follow upDEVICE

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.

Additional sequences and extra MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis according to the IPSCSG Definitions (22)
  • Age ≥ 18
  • Able to give informed consent
  • Clinically suspicious for a dominant stricture

You may not qualify if:

  • insufficient image quality
  • known allergy for MRI contrast agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • Ponsioen CY, Arnelo U, Bergquist A, Rauws EA, Paulsen V, Cantu P, Parzanese I, De Vries EM, van Munster KN, Said K, Chazouilleres O, Desaint B, Kemgang A, Farkkila M, Van der Merwe S, Van Steenbergen W, Marschall HU, Stotzer PO, Thorburn D, Pereira SP, Aabakken L. No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. Gastroenterology. 2018 Sep;155(3):752-759.e5. doi: 10.1053/j.gastro.2018.05.034. Epub 2018 May 24.

    PMID: 29803836BACKGROUND

  • Lazaridis KN, LaRusso NF. Primary Sclerosing Cholangitis. N Engl J Med. 2016 Sep 22;375(12):1161-70. doi: 10.1056/NEJMra1506330. No abstract available.

    PMID: 27653566BACKGROUND

  • Zheng HH, Jiang XL. Increased risk of colorectal neoplasia in patients with primary sclerosing cholangitis and inflammatory bowel disease: a meta-analysis of 16 observational studies. Eur J Gastroenterol Hepatol. 2016 Apr;28(4):383-90. doi: 10.1097/MEG.0000000000000576.

    PMID: 26938805BACKGROUND

  • Barner-Rasmussen N, Pukkala E, Jussila A, Farkkila M. Epidemiology, risk of malignancy and patient survival in primary sclerosing cholangitis: a population-based study in Finland. Scand J Gastroenterol. 2020 Jan;55(1):74-81. doi: 10.1080/00365521.2019.1707277. Epub 2020 Jan 4.

    PMID: 31902255BACKGROUND

  • Boonstra K, Weersma RK, van Erpecum KJ, Rauws EA, Spanier BW, Poen AC, van Nieuwkerk KM, Drenth JP, Witteman BJ, Tuynman HA, Naber AH, Kingma PJ, van Buuren HR, van Hoek B, Vleggaar FP, van Geloven N, Beuers U, Ponsioen CY; EpiPSCPBC Study Group. Population-based epidemiology, malignancy risk, and outcome of primary sclerosing cholangitis. Hepatology. 2013 Dec;58(6):2045-55. doi: 10.1002/hep.26565. Epub 2013 Oct 17.

    PMID: 23775876BACKGROUND

  • Hirschfield GM, Karlsen TH, Lindor KD, Adams DH. Primary sclerosing cholangitis. Lancet. 2013 Nov 9;382(9904):1587-99. doi: 10.1016/S0140-6736(13)60096-3. Epub 2013 Jun 28.

    PMID: 23810223BACKGROUND

  • Ponsioen CY, Chapman RW, Chazouilleres O, Hirschfield GM, Karlsen TH, Lohse AW, Pinzani M, Schrumpf E, Trauner M, Gores GJ. Surrogate endpoints for clinical trials in primary sclerosing cholangitis: Review and results from an International PSC Study Group consensus process. Hepatology. 2016 Apr;63(4):1357-67. doi: 10.1002/hep.28256. Epub 2015 Dec 23.

    PMID: 26418478BACKGROUND

  • Ponsioen CY, Reitsma JB, Boberg KM, Aabakken L, Rauws EA, Schrumpf E. Validation of a cholangiographic prognostic model in primary sclerosing cholangitis. Endoscopy. 2010 Sep;42(9):742-7. doi: 10.1055/s-0030-1255527. Epub 2010 Jul 9.

    PMID: 20623444BACKGROUND

  • Lindor KD, Kowdley KV, Harrison ME; American College of Gastroenterology. ACG Clinical Guideline: Primary Sclerosing Cholangitis. Am J Gastroenterol. 2015 May;110(5):646-59; quiz 660. doi: 10.1038/ajg.2015.112. Epub 2015 Apr 14.

    PMID: 25869391BACKGROUND

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.

    PMID: 19501929BACKGROUND

  • Berstad AE, Aabakken L, Smith HJ, Aasen S, Boberg KM, Schrumpf E. Diagnostic accuracy of magnetic resonance and endoscopic retrograde cholangiography in primary sclerosing cholangitis. Clin Gastroenterol Hepatol. 2006 Apr;4(4):514-20. doi: 10.1016/j.cgh.2005.10.007.

    PMID: 16616358BACKGROUND

  • Dave M, Elmunzer BJ, Dwamena BA, Higgins PD. Primary sclerosing cholangitis: meta-analysis of diagnostic performance of MR cholangiopancreatography. Radiology. 2010 Aug;256(2):387-96. doi: 10.1148/radiol.10091953.

    PMID: 20656832BACKGROUND

  • Lunder AK, Hov JR, Borthne A, Gleditsch J, Johannesen G, Tveit K, Viktil E, Henriksen M, Hovde O, Huppertz-Hauss G, Hoie O, Hoivik ML, Monstad I, Solberg IC, Jahnsen J, Karlsen TH, Moum B, Vatn M, Negard A. Prevalence of Sclerosing Cholangitis Detected by Magnetic Resonance Cholangiography in Patients With Long-term Inflammatory Bowel Disease. Gastroenterology. 2016 Oct;151(4):660-669.e4. doi: 10.1053/j.gastro.2016.06.021. Epub 2016 Jun 21.

    PMID: 27342213BACKGROUND

  • Zenouzi R, Welle CL, Venkatesh SK, Schramm C, Eaton JE. Magnetic Resonance Imaging in Primary Sclerosing Cholangitis-Current State and Future Directions. Semin Liver Dis. 2019 Jul;39(3):369-380. doi: 10.1055/s-0039-1687853. Epub 2019 Apr 30.

    PMID: 31041791BACKGROUND

  • Goldfinger MH, Ridgway GR, Ferreira C, Langford CR, Cheng L, Kazimianec A, Borghetto A, Wright TG, Woodward G, Hassanali N, Nicholls RC, Simpson H, Waddell T, Vikal S, Mavar M, Rymell S, Wigley I, Jacobs J, Kelly M, Banerjee R, Brady JM. Quantitative MRCP Imaging: Accuracy, Repeatability, Reproducibility, and Cohort-Derived Normative Ranges. J Magn Reson Imaging. 2020 Sep;52(3):807-820. doi: 10.1002/jmri.27113. Epub 2020 Mar 8.

    PMID: 32147892BACKGROUND

  • Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12.

    PMID: 24036007BACKGROUND

  • Pavlides M, Banerjee R, Tunnicliffe EM, Kelly C, Collier J, Wang LM, Fleming KA, Cobbold JF, Robson MD, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging for the assessment of non-alcoholic fatty liver disease severity. Liver Int. 2017 Jul;37(7):1065-1073. doi: 10.1111/liv.13284. Epub 2017 May 30.

    PMID: 27778429BACKGROUND

  • Bradley CR, Cox EF, Scott RA, James MW, Kaye P, Aithal GP, Francis ST, Guha IN. Multi-organ assessment of compensated cirrhosis patients using quantitative magnetic resonance imaging. J Hepatol. 2018 Nov;69(5):1015-1024. doi: 10.1016/j.jhep.2018.05.037. Epub 2018 Jun 8.

    PMID: 29886155BACKGROUND

  • Selvaraj EA, Culver EL, Coller J. Combination of quantitative MRCP and MRI demonstrates increased periductal iron-corrected T1 in primary sclerosing cholangitis. Gut. 2021;70:A155

    BACKGROUND

  • Ponsioen CY, Assis DN, Boberg KM, Bowlus CL, Deneau M, Thorburn D, Aabakken L, Farkkila M, Petersen B, Rupp C, Hubscher SG; PSC Study Group. Defining Primary Sclerosing Cholangitis: Results From an International Primary Sclerosing Cholangitis Study Group Consensus Process. Gastroenterology. 2021 Dec;161(6):1764-1775.e5. doi: 10.1053/j.gastro.2021.07.046. Epub 2021 Aug 10. No abstract available.

    PMID: 34384749BACKGROUND

MeSH Terms

Interventions

Cholangiopancreatography, Magnetic Resonance

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive System

Study Officials

  • Cyriel Ponsioen, MD PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim E Middelburg, MSc

CONTACT

+31648510414t.e.middelburg@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective, observational study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 23, 2022

First Posted

May 4, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

December 1, 2023

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Until 5 years after publication
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