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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Fibrosis
- Sponsor
- Ente Ospedaliero Ospedali Galliera
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- liver stiffness
- Last Updated
- 8 years ago
Overview
Brief 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).
Investigators
Gian Andrea Rollandi
Direttore medico responsabile S.C. Radiodiagnostica
Ente Ospedaliero Ospedali Galliera
Eligibility Criteria
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)
Outcomes
Primary Outcomes
liver stiffness
Time Frame: 18 months
liver stiffness is indicated in kPa
Secondary Outcomes
- liver steatosis(18 months)
- liver iron overload(18 months)