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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00243633
First received: October 21, 2005
Last updated: March 18, 2008
Last verified: March 2008
  Purpose

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
Focal Liver Lesions
Liver Cancer
Liver Cirrhosis
Procedure: Real-time contrast-enhanced ultrasound sonography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Medical and economic interest of CEUS

Secondary Outcome Measures:
  • Method acceptability
  • Contrast-enhanced ultrasound sonography tolerance
  • Harmony inter-readers

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243633

Locations
France
CHRU d'ANGERS
Angers, France, 49033
Hôpital Saint-Jacques, CHRU Besancon
Besançon, France, 25000
Hôpital Saint-André, CHRU Bordeaux
Bordeaux, France, 33075
Hôpital Beaujon, Assistance Publique Hôpitaux de Paris
Clichy, France, 92118
Hospices Civils de Lyon
Lyon, France, 69003
Hôpital Saint-Eloi, CHRU Montpellier
Montpellier, France, 34295
Hôpital Necker, Assistance Publique Hôpitaux de Paris
Paris, France, 75743
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
Paris, France, 75651
Hôpital La Milétrie, CHRU Poitiers
Poitiers, France, 86000
Hôpital Robert Debré, CHRU Reims
Reims, France, 51092
Hôpital Nord, CHRU Saint-Etienne
Saint-Etienne, France, 42055
Hôpital Bretonneau, CHRU Tours
Tours, France, 37044
Service de Radiologie, Hôpital d'Enfants de Brabois
Vandoeuvre les Nancy, France, 54511
Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Tours
Ministry of Health, France
Investigators
Principal Investigator: Jean Michel CORREAS, Dr Necker Hospital
Study Director: François TRANQUART, Pr University Hospital, Tours
  More Information

Publications:

Responsible Party: University Hospital Tours
ClinicalTrials.gov Identifier: NCT00243633     History of Changes
Other Study ID Numbers: CIT 05 - FT / ECUS
Study First Received: October 21, 2005
Last Updated: March 18, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
focal liver lesions
contrast-enhanced ultrasound sonography
cirrhosis
suspected liver metastases
suspected liver cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014