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

Not Applicable

Completed

• Conditions: Focal Liver Lesions; Liver Cancer; Liver Cirrhosis

• Registration Number: NCT00243633
• Lead Sponsor: University Hospital, Tours

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-24
• Primary Completion: 2006-12
• Study Completion: 2007-08
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-18
• Last Update Posted: 2008-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 878

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Medical and economic interest of CEUS

Secondary Outcome Measures

Name	Time	Method
Method acceptability
Contrast-enhanced ultrasound sonography tolerance
Harmony inter-readers

Trial Locations

Locations (15)

Hôpital Saint-Jacques, CHRU Besancon; 🇫🇷 Besançon, France

Hôpital Saint-Eloi, CHRU Montpellier; 🇫🇷 Montpellier, France

Hôpital Bretonneau, CHRU Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHRU d'ANGERS; 🇫🇷 Angers, France

Hôpital Saint-André, CHRU Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Beaujon, Assistance Publique Hôpitaux de Paris; 🇫🇷 Clichy, France

Hôpital La Milétrie, CHRU Poitiers; 🇫🇷 Poitiers, France

Hôpital Necker, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France

Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France

Hôpital Nord, CHRU Saint-Etienne; 🇫🇷 Saint-Etienne, France

Service de Radiologie, Hôpital d'Enfants de Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Hôpital Robert Debré, CHRU Reims; 🇫🇷 Reims, France

Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris; 🇫🇷 Villejuif, France