Disease Status in Primary Sclerosing Cholangitis by Elastography
Primary Purpose
Primary Sclerosing Cholangitis, Elastography, Hepatic Fibrosis
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MR Elastography (MRE) and FibroScan
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Sclerosing Cholangitis
Eligibility Criteria
Inclusion Criteria:
- Patients with known PSC
- Control group of patients with Non-PSC chronic liver disease with recent (<3month) liver biopsy and under imaging surveillance.
Exclusion Criteria:
- General Contraindications to MRI such as pacemaker, brain aneurysm clips etc.
- Pregnancy
Sites / Locations
- University Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PSC Patients
Non-PSC Patients
Arm Description
MR Elastography, Fibroscan and standard of care biopsy
MR Elastography, Fibroscan and standard of care biopsy
Outcomes
Primary Outcome Measures
Validation of fibrosis quantification via MR Elastography
Secondary Outcome Measures
Full Information
NCT ID
NCT02446665
First Posted
February 20, 2015
Last Updated
May 18, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02446665
Brief Title
Disease Status in Primary Sclerosing Cholangitis by Elastography
Official Title
Comprehensive Evaluation of Disease Status in Primary Sclerosing Cholangitis by MRCP and MR Elastography Through Hepatic Fibrosis Estimation With Comparison to FibroScan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver cirrhosis, liver failure and liver cancer. Assessment of disease status is important to determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker for monitoring disease status in PSC. Successful outcomes will provide an opportunity for optimal treatment triage including liver transplantation via accurate and non-invasive estimation of true disease status in PSC.
Detailed Description
Primary sclerosing cholangitis (PSC) is a chronic liver disease that causes inflammation and obstruction of bile ducts. It can eventually lead to liver cirrhosis due to fibrosis, liver failure and liver cancer. The diagnosis of PSC is challenging as there is no single diagnostic test and usually involves a multidisciplinary approach with MRI playing a major role. Assessment of disease status is important to triage patients for optimal treatment including liver transplantation and prevention of liver failure. There are however no established blood tests that can reliably track the disease progression and repeated liver biopsies have multiple drawbacks including complications, costs and feasibility. There is a dire need of an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker for monitoring disease status in PSC. The patients would have or will agree to undergo a liver FibroScan examination to grade fibrosis within 3 months of the MRI examination. In addition to the standard protocol liver and biliary MR examination including MRCP and contrast enhanced imaging, MRE will be added to the study exam following informed consent. A control group of non-PSC subjects with known chronic liver disease such as chronic viral hepatitis who have had liver biopsy and FibroScan within similar time frame of 3 months, to assess fibrosis grade will also undergo MR Elastography in order to validate the results of fibrosis by MRE. The study has significant implications for care of patients with PSC. Successful outcomes will provide an opportunity for optimal treatment triage including liver transplantation via accurate and non-invasive estimation of true disease status in PSC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis, Elastography, Hepatic Fibrosis, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSC Patients
Arm Type
Experimental
Arm Description
MR Elastography, Fibroscan and standard of care biopsy
Arm Title
Non-PSC Patients
Arm Type
Active Comparator
Arm Description
MR Elastography, Fibroscan and standard of care biopsy
Intervention Type
Device
Intervention Name(s)
MR Elastography (MRE) and FibroScan
Primary Outcome Measure Information:
Title
Validation of fibrosis quantification via MR Elastography
Time Frame
The elastography will be done at the time when the participant would be undergoing their normal clinical care, at the time specified by the primary care physician's order (within 3 months of the MRI examination)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with known PSC
Control group of patients with Non-PSC chronic liver disease with recent (<3month) liver biopsy and under imaging surveillance.
Exclusion Criteria:
General Contraindications to MRI such as pacemaker, brain aneurysm clips etc.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartik Jhaveri, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2L7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Disease Status in Primary Sclerosing Cholangitis by Elastography
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