Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

Ente Ospedaliero Ospedali Galliera

Status: Unknown

Conditions: Liver Fibrosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03293953

41UCS2016

Details and patient eligibility

About

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).

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV).

Exclusion criteria

• contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)