MRI, PSC
Conditions
Keywords
Liver Multiscan, MRCP+
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.
Interventions
DIAGNOSTIC_TESTLiver Multiscan sequences baseline
Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.
DEVICEMRCP+ analysis baseline
Post processing tool (Software) for quantifying MRCP images after MRCP is performed. Patient involvement is not necessary during this procedure.
DEVICELiver Multiscan analysis baseline
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.
DIAGNOSTIC_TESTMRI liver with MRCP
An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol
DIAGNOSTIC_TESTLiver Multiscan sequences follow-up
Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.
DEVICEMRCP+ analysis follow up
Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.
DEVICELiver Multiscan analysis follow up
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.
Sponsors
Perspectum
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 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. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 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. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 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 | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 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. |
Contacts
Primary ContactTim E Middelburg, MSc
Outcome results
None listed