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

March 18, 2008 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

878

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHRU d'Angers
      • Besançon, France, 25000
        • Hôpital Saint-Jacques, CHRU Besancon
      • Bordeaux, France, 33075
        • Hôpital Saint-André, CHRU Bordeaux
      • Clichy, France, 92118
        • Hôpital Beaujon, Assistance Publique Hôpitaux de Paris
      • Lyon, France, 69003
        • Hospices Civils de Lyon
      • Montpellier, France, 34295
        • Hôpital Saint-Eloi, CHRU Montpellier
      • Paris, France, 75651
        • Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
      • Paris, France, 75743
        • Hôpital Necker, Assistance Publique Hôpitaux de Paris
      • Poitiers, France, 86000
        • Hôpital La Milétrie, CHRU Poitiers
      • Reims, France, 51092
        • Hôpital Robert Debré, CHRU Reims
      • Saint-Etienne, France, 42055
        • Hôpital Nord, CHRU Saint-Etienne
      • Tours, France, 37044
        • Hôpital Bretonneau, CHRU Tours
      • Vandoeuvre les Nancy, France, 54511
        • Service de Radiologie, Hôpital d'Enfants de Brabois
      • Villejuif, France, 94805
        • Institut Gustave Roussy
      • Villejuif, France, 94804
        • Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Medical and economic interest of CEUS

Secondary Outcome Measures

Outcome Measure
Method acceptability
Contrast-enhanced ultrasound sonography tolerance
Harmony inter-readers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Jean Michel CORREAS, Dr, Necker Hospital
  • Study Director: François TRANQUART, Pr, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 18, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIT 05 - FT / ECUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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