Disease Status in Primary Sclerosing Cholangitis by Elastography

NCT02446665 | Active Not Recruiting

• 1 other identifier: 12-5707
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis; Elastography; Hepatic Fibrosis; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Validation of fibrosis quantification via MR Elastography

  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)

Study Arms (2)

PSC Patients

EXPERIMENTAL

MR Elastography, Fibroscan and standard of care biopsy

Device: MR Elastography (MRE) and FibroScan

Non-PSC Patients

ACTIVE COMPARATOR

MR Elastography, Fibroscan and standard of care biopsy

Device: MR Elastography (MRE) and FibroScan

Interventions

MR Elastography (MRE) and FibroScan DEVICE

Non-PSC Patients; PSC Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known PSC
• Control group of patients with Non-PSC chronic liver disease with recent (\<3month) liver biopsy and under imaging surveillance.

You may not qualify if:

• General Contraindications to MRI such as pacemaker, brain aneurysm clips etc.
• Pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2L7, Canada

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing; Liver Cirrhosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kartik Jhaveri, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: May 18, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CA (1)