Clinical trial NCT03293953: Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
Keywords: HCV
HIV
Liver Fibrosis
Liver Iron Overload
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2017-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV)

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).

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)

Primary outcomes:
measure: liver stiffness
timeFrame: 18 months
Secondary outcomes:
measure: liver iron overload
timeFrame: 18 months
measure: liver steatosis
timeFrame: 18 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: SC Radiodiagnostica
Study officials:
affiliation: Direttore SC Radiodiagnostica, Coordinatore Scientifico EO Ospedali Galliera Genova-Italy
name: Gian Andrea Rollandi, MD
role: PRINCIPAL_INVESTIGATOR
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