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
About this trial
This is an interventional diagnostic trial for PSC focused on measuring Liver Multiscan, MRCP+
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
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
NCT ID
NCT05359497
First Posted
March 23, 2022
Last Updated
April 29, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Perspectum
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
Citations:
PubMed Identifier
29803836
Citation
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.
Results Reference
background
PubMed Identifier
27653566
Citation
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.
Results Reference
background
PubMed Identifier
26938805
Citation
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.
Results Reference
background
PubMed Identifier
31902255
Citation
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.
Results Reference
background
PubMed Identifier
23775876
Citation
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.
Results Reference
background
PubMed Identifier
23810223
Citation
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.
Results Reference
background
PubMed Identifier
26418478
Citation
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.
Results Reference
background
PubMed Identifier
20623444
Citation
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.
Results Reference
background
PubMed Identifier
25869391
Citation
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.
Results Reference
background
PubMed Identifier
19501929
Citation
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.
Results Reference
background
PubMed Identifier
16616358
Citation
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.
Results Reference
background
PubMed Identifier
20656832
Citation
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.
Results Reference
background
PubMed Identifier
27342213
Citation
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.
Results Reference
background
PubMed Identifier
31041791
Citation
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.
Results Reference
background
PubMed Identifier
32147892
Citation
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.
Results Reference
background
PubMed Identifier
24036007
Citation
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.
Results Reference
background
PubMed Identifier
27778429
Citation
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.
Results Reference
background
PubMed Identifier
29886155
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
34384749
Citation
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.
Results Reference
background
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Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
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