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Sponsors and Collaborators: |
University Hospital, Tours Ministry of Health, France |
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Information provided by: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT00243633 |
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.
Condition | Intervention |
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Focal Liver Lesions Liver Cancer Liver Cirrhosis |
Procedure: Real-time contrast-enhanced ultrasound sonography |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS) |
Enrollment: | 878 |
Study Start Date: | April 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
myocardial infarction, recent coronary artery intervention, acute cardiac failure (within last month), acute endocarditis and prosthetic valves.
France | |
Hôpital Bretonneau, CHRU Tours | |
TOURS, France, 37044 | |
CHRU d'ANGERS | |
ANGERS, France, 49033 | |
Hôpital Saint-André, CHRU Bordeaux | |
BORDEAUX, France, 33075 | |
Hôpital Beaujon, Assistance Publique Hôpitaux de Paris | |
CLICHY, France, 92118 | |
Service de Radiologie, Hôpital d'Enfants de Brabois | |
Vandoeuvre les Nancy, France, 54511 | |
Hôpital Robert Debré, CHRU Reims | |
REIMS, France, 51092 | |
Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris | |
Villejuif, France, 94804 | |
Hospices Civils de Lyon | |
LYON, France, 69003 | |
Hôpital Necker, Assistance Publique Hôpitaux de Paris | |
PARIS, France, 75743 | |
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris | |
PARIS, France, 75651 | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Hôpital Nord, CHRU Saint-Etienne | |
Saint-Etienne, France, 42055 | |
Hôpital Saint-Jacques, CHRU Besancon | |
Besançon, France, 25000 | |
Hôpital La Milétrie, CHRU Poitiers | |
Poitiers, France, 86000 | |
Hôpital Saint-Eloi, CHRU Montpellier | |
MONTPELLIER, France, 34295 |
Principal Investigator: | Jean Michel CORREAS, Dr | Necker Hospital |
Study Director: | François TRANQUART, Pr | University Hospital, Tours |
Responsible Party: | ( University Hospital Tours ) |
Study ID Numbers: | CIT 05 - FT / ECUS |
Study First Received: | October 21, 2005 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00243633 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
focal liver lesions contrast-enhanced ultrasound sonography cirrhosis suspected liver metastases suspected liver cirrhosis |
Liver Neoplasms Liver Diseases Digestive System Neoplasms Digestive System Diseases |
Fibrosis Neoplasm Metastasis Gastrointestinal Neoplasms Liver Cirrhosis |
Liver Neoplasms Neoplasms Liver Diseases Neoplasms by Site Digestive System Neoplasms |
Pathologic Processes Digestive System Diseases Fibrosis Liver Cirrhosis |