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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03293953

Acronym

FULLFIBRO01

Enrollment

100

Registered

2017-09-26

Start date

2017-05-01

Completion date

2018-11-01

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Keywords

HCV, HIV, Liver Fibrosis, Liver Iron Overload

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
liver stiffness	18 months	liver stiffness is indicated in kPa

Secondary

Measure	Time frame	Description
liver iron overload	18 months	liver iron concentration (LIC) is indicated in mg/g dw
liver steatosis	18 months	liver steatosis

Countries

Italy

Contacts

Primary ContactGian Andrea Rollandi, MD

gianandrea.rollandi@galliera.it0039010563

Backup ContactAlessandra Argusti, PhD

alessandra.argusti@galliera.it0039010563

Outcome results