Disease Status in Primary Sclerosing Cholangitis by Elastography

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases Elastography Fibrosis Hepatic Fibrosis Liver Cirrhosis Liver Diseases Magnetic Resonance Imaging Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2L7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Elastography (MRE) and FibroScan

Device

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Comprehensive Evaluation of Disease Status in Primary Sclerosing Cholangitis by MRCP and MR Elastography Through Hepatic Fibrosis Estimation With Comparison to FibroScan

Important dates

Study start: 2014
Primary completion: 2025
Study completion: 2025
First posted: May 18, 2015
Registry last updated: Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting