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Disease Status in Primary Sclerosing Cholangitis by Elastography

This study has suspended participant recruitment.
(A key study collaborator is on a temporary leave of absence)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02446665
First received: February 20, 2015
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Primary Sclerosing Cholangitis Elastography Hepatic Fibrosis Magnetic Resonance Imaging Device: MR Elastography (MRE) and FibroScan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comprehensive Evaluation of Disease Status in Primary Sclerosing Cholangitis by MRCP and MR Elastography Through Hepatic Fibrosis Estimation With Comparison to FibroScan

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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) ]

Estimated Enrollment: 120
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PSC Patients
MR Elastography, Fibroscan and standard of care biopsy
Device: MR Elastography (MRE) and FibroScan
Active Comparator: Non-PSC Patients
MR Elastography, Fibroscan and standard of care biopsy
Device: MR Elastography (MRE) and FibroScan

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02446665

Locations
Canada, Ontario
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2L7
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kartik Jhaveri, MD University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02446665     History of Changes
Other Study ID Numbers: 12-5707-AE
Study First Received: February 20, 2015
Last Updated: October 27, 2016

Additional relevant MeSH terms:
Fibrosis
Cholangitis
Cholangitis, Sclerosing
Liver Cirrhosis
Pathologic Processes
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on June 27, 2017