Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

Study Overview
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Brief Summary
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The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution. These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient. The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.

Official Title
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Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

Conditions
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Focal Liver Lesions, Liver Cancer, Liver Cirrhosis

Intervention / Treatment
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* Procedure: Real-time contrast-enhanced ultrasound sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target focal liver lesion of size lower than 10 cm and higher than 5 mm detected by conventional ultrasonography Exclusion Criteria: Patients with acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: myocardial infarction, recent coronary artery intervention, acute cardiac failure (within last month), acute endocarditis and prosthetic valves. Pregnant and lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Real-time contrast-enhanced ultrasound sonography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical and economic interest of CEUS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method acceptability |  |  | 
| Contrast-enhanced ultrasound sonography tolerance |  |  | 
| Harmony inter-readers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal liver lesions, contrast-enhanced ultrasound sonography, cirrhosis, suspected liver metastases, suspected liver cirrhosis