Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01) — FULLFIBRO01  

Liver Fibrosis Clinical Trial

Official title: Prospective Comparison Between Transient Elastography (TE), Shear Wave Elastography (SWE) and Magnetic Resonance Elastography (MRE) for Non-invasive Assessment of Liver Fibrosis in Patients Affected by Chronic Viral Hepatitis

Status Recruiting

Clinical Trial Summary

The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Clinical Trial Description

Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE.

Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities.

Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV). ;

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

• NCT number: NCT03293953
• Study type: Observational
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Gian Andrea Rollandi, MD
• Phone: 0039010563
• Email: gianandrea.rollandi@galliera.it
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Completion date: November 1, 2018