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

Sponsors and Collaborators:	University Hospital, Tours Ministry of Health, France
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00243633

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:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cirrhosis Liver Cancer Ultrasound

U.S. FDA Resources

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

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

Locations

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

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:

Kim TK, Choi BI, Hong HS, Choi BY, Han JK. Improved imaging of hepatic metastases with delayed pulse inversion harmonic imaging using a contrast agent SH U 508A: preliminary study. Ultrasound Med Biol. 2000 Nov;26(9):1439-44.

Albrecht T, Blomley MJ, Burns PN, Wilson S, Harvey CJ, Leen E, Claudon M, Calliada F, Correas JM, LaFortune M, Campani R, Hoffmann CW, Cosgrove DO, LeFevre F. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology. 2003 May;227(2):361-70. Epub 2003 Mar 20.

Quaia E, Bertolotto M, Forgacs B, Rimondini A, Locatelli M, Mucelli RP. Detection of liver metastases by pulse inversion harmonic imaging during Levovist late phase: comparison with conventional ultrasound and helical CT in 160 patients. Eur Radiol. 2003 Mar;13(3):475-83. Epub 2002 Sep 26.

Bernatik T, Becker D, Neureiter D, Hansler J, Frieser M, Schaber S, Hahn EG, Strobel D. [Detection of liver metastases--comparison of contrast--enhanced ultrasound using first versus second generation contrast agents] Ultraschall Med. 2003 Jun;24(3):175-9. German.

Basilico R, Blomley MJ, Harvey CJ, Filippone A, Heckemann RA, Eckersley RJ, Cosgrove DO. Which continuous US scanning mode is optimal for the detection of vascularity in liver lesions when enhanced with a second generation contrast agent? Eur J Radiol. 2002 Mar;41(3):184-91.

Leen E, Angerson WJ, Yarmenitis S, Bongartz G, Blomley M, Del Maschio A, Summaria V, Maresca G, Pezzoli C, Llull JB. Multi-centre clinical study evaluating the efficacy of SonoVue (BR1), a new ultrasound contrast agent in Doppler investigation of focal hepatic lesions. Eur J Radiol. 2002 Mar;41(3):200-6.

Tranquart F, Bleuzen A, Tchuenbou J. [Contrast ultrasound imaging in focal liver lesions: diagnostic value and guidelines] J Radiol. 2004 May;85(5 Pt 2):680-9. Review. French.

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

Keywords provided by University Hospital, Tours:

focal liver lesions
contrast-enhanced ultrasound sonography
cirrhosis
suspected liver metastases
suspected liver cirrhosis

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Neoplasms
Digestive System Diseases

Fibrosis
Neoplasm Metastasis
Gastrointestinal Neoplasms
Liver Cirrhosis

Additional relevant MeSH terms:

Liver Neoplasms
Neoplasms
Liver Diseases
Neoplasms by Site
Digestive System Neoplasms

Pathologic Processes
Digestive System Diseases
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this record on September 10, 2009