Clinical trial NCT00243633: Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)
Official title: Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focal Liver Lesions
Liver Cancer
Liver Cirrhosis
Keywords: focal liver lesions
contrast-enhanced ultrasound sonography
cirrhosis
suspected liver metastases
suspected liver cirrhosis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-10-24
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Medical and economic interest of CEUS
Secondary outcomes:
measure: Method acceptability
measure: Contrast-enhanced ultrasound sonography tolerance
measure: Harmony inter-readers
Other outcomes:
Locations:
city: Angers
country: France
facility: CHRU d'ANGERS
city: Besançon
country: France
facility: Hôpital Saint-Jacques, CHRU Besancon
city: Bordeaux
country: France
facility: Hôpital Saint-André, CHRU Bordeaux
city: Clichy
country: France
facility: Hôpital Beaujon, Assistance Publique Hôpitaux de Paris
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: Hôpital Saint-Eloi, CHRU Montpellier
city: Paris
country: France
facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Necker, Assistance Publique Hôpitaux de Paris
city: Poitiers
country: France
facility: Hôpital La Milétrie, CHRU Poitiers
city: Reims
country: France
facility: Hôpital Robert Debré, CHRU Reims
city: Saint-Etienne
country: France
facility: Hôpital Nord, CHRU Saint-Etienne
city: Tours
country: France
facility: Hôpital Bretonneau, CHRU Tours
city: Vandoeuvre les Nancy
country: France
facility: Service de Radiologie, Hôpital d'Enfants de Brabois
city: Villejuif
country: France
facility: Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Necker Hospital
name: Jean Michel CORREAS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Tours
name: François TRANQUART, Pr
role: STUDY_DIRECTOR
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