NCT03293953

Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Ente Ospedaliero Ospedali Galliera · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Liver Fibrosis

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2017-09-26
• Last updated: 2017-09-26

Locations

1 site across 1 country: Italy