Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

• Conditions: Liver Fibrosis

• Registration Number: NCT03293953
• Lead Sponsor: Ente Ospedaliero Ospedali Galliera

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).

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Last Update Submitted: 2017-09-21
• Study First Posted: 2017-09-26
• Last Update Posted: 2017-09-26
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
liver stiffness	18 months	liver stiffness is indicated in kPa

Secondary Outcome Measures

Name	Time	Method
liver steatosis	18 months	liver steatosis
liver iron overload	18 months	liver iron concentration (LIC) is indicated in mg/g dw

Trial Locations

Locations (1)

SC Radiodiagnostica; 🇮🇹 Genova, Italy