Disease Status in Primary Sclerosing Cholangitis by Elastography

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02446665
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 2014
Completion date	December 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03785171` - Predicative Value of Multimodal MRI in Moyamoya Disease
Not yet recruiting	`NCT03726788` - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis	Phase 2
Active, not recruiting	`NCT01956409` - Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis	Phase 4
Completed	`NCT01660841` - Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging	Phase 3
Recruiting	`NCT03635619` - The Application of 3T MRI in Esophageal Cancer
Recruiting	`NCT03658343` - T2* MRI Analysis for Sarcoma	N/A
Recruiting	`NCT04555642` - Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Active, not recruiting	`NCT03441867` - Neuroimaging Biomarker for Seizures	N/A
Recruiting	`NCT04850001` - Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study
Not yet recruiting	`NCT05816213` - Point-of-care Low-field MRI in Acute Stroke
Active, not recruiting	`NCT05498623` - MR Fingerprinting for Diagnostic of Prostate Cancer
Recruiting	`NCT04996615` - Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women
Recruiting	`NCT04257747` - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI	N/A
Recruiting	`NCT05889117` - Brain Stimulation for Concussion	N/A
Completed	`NCT02540967` - Drug Use Investigation of Gadovist.
Completed	`NCT05103189` - 4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension	N/A
Completed	`NCT02567318` - Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?	N/A
Recruiting	`NCT02834585` - Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT)	N/A
Completed	`NCT01721785` - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	N/A
Completed	`NCT01223404` - Nicotinic Modulation of the Default Network	N/A