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

NCT ID: NCT00243633

Last Updated: 2008-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Focal Liver Lesions Liver Cancer Liver Cirrhosis

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Real-time contrast-enhanced ultrasound sonography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Principal Investigators

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Jean Michel CORREAS, Dr

Role: PRINCIPAL_INVESTIGATOR

Necker Hospital

François TRANQUART, Pr

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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CHRU d'ANGERS

Angers, , France

Site Status

Hôpital Saint-Jacques, CHRU Besancon

Besançon, , France

Site Status

Hôpital Saint-André, CHRU Bordeaux

Bordeaux, , France

Site Status

Hôpital Beaujon, Assistance Publique Hôpitaux de Paris

Clichy, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Hôpital Saint-Eloi, CHRU Montpellier

Montpellier, , France

Site Status

Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status

Hôpital Necker, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status

Hôpital La Milétrie, CHRU Poitiers

Poitiers, , France

Site Status

Hôpital Robert Debré, CHRU Reims

Reims, , France

Site Status

Hôpital Nord, CHRU Saint-Etienne

Saint-Etienne, , France

Site Status

Hôpital Bretonneau, CHRU Tours

Tours, , France

Site Status

Service de Radiologie, Hôpital d'Enfants de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

Villejuif, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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. doi: 10.1016/s0301-5629(00)00268-4.

Reference Type BACKGROUND
PMID: 11179618 (View on PubMed)

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. doi: 10.1148/radiol.2272011833. Epub 2003 Mar 20.

Reference Type BACKGROUND
PMID: 12649417 (View on PubMed)

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. doi: 10.1007/s00330-002-1670-1. Epub 2002 Sep 26.

Reference Type BACKGROUND
PMID: 12594549 (View on PubMed)

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. doi: 10.1055/s-2003-40060. German.

Reference Type BACKGROUND
PMID: 12817311 (View on PubMed)

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. doi: 10.1016/s0720-048x(01)00459-4.

Reference Type BACKGROUND
PMID: 11861092 (View on PubMed)

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. doi: 10.1016/s0720-048x(01)00457-0.

Reference Type BACKGROUND
PMID: 11861094 (View on PubMed)

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. doi: 10.1016/s0221-0363(04)97649-4. French.

Reference Type BACKGROUND
PMID: 15238869 (View on PubMed)

Other Identifiers

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CIT 05 - FT / ECUS

Identifier Type: -

Identifier Source: org_study_id