Characterization of Focal Liver Lesions by Real-time Contrast-enhanced Ultrasound Imaging (CEUS)

NCT00243633 | Completed

• 1 other identifier: CIT 05 - FT / ECUS
• Study Type: interventional
• Target: 878
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Focal Liver Lesions; Liver Cancer; Liver Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Medical and economic interest of CEUS

Secondary Outcomes (3)

• Method acceptability

• Contrast-enhanced ultrasound sonography tolerance

• Harmony inter-readers

Interventions

Real-time contrast-enhanced ultrasound sonography PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Target focal liver lesion of size lower than 10 cm and higher than 5 mm detected by conventional ultrasonography

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead
• Ministry of Health, France: collaborator

Study Sites (15)

CHRU d'ANGERS

Angers, 49033, France

Location

Hôpital Saint-Jacques, CHRU Besancon

Besançon, 25000, France

Location

Hôpital Saint-André, CHRU Bordeaux

Bordeaux, 33075, France

Location

Hôpital Beaujon, Assistance Publique Hôpitaux de Paris

Clichy, 92118, France

Location

Hospices Civils de Lyon

Lyon, 69003, France

Location

Hôpital Saint-Eloi, CHRU Montpellier

Montpellier, 34295, France

Location

Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris

Paris, 75651, France

Location

Hôpital Necker, Assistance Publique Hôpitaux de Paris

Paris, 75743, France

Location

Hôpital La Milétrie, CHRU Poitiers

Poitiers, 86000, France

Location

Hôpital Robert Debré, CHRU Reims

Reims, 51092, France

Location

Hôpital Nord, CHRU Saint-Etienne

Saint-Etienne, 42055, France

Location

Hôpital Bretonneau, CHRU Tours

Tours, 37044, France

Location

Service de Radiologie, Hôpital d'Enfants de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (8)

• 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.

  PMID: 11179618 BACKGROUND

• 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.

  PMID: 12649417 BACKGROUND

• 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.

  PMID: 12594549 BACKGROUND

• 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.

  PMID: 12817311 BACKGROUND

• 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.

  PMID: 11861092 BACKGROUND

• 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.

  PMID: 11861094 BACKGROUND

• 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.

  PMID: 15238869 BACKGROUND

• Tranquart F, Correas JM, Ladam Marcus V, Manzoni P, Vilgrain V, Aube C, Elmaleh A, Chami L, Claudon M, Cuilleron M, Diris B, Garibaldi F, Lucidarme O, Marion D, Beziat C, Rode A, Tasu JP, Trillaud H, Bleuzen A, Le Gouge A, Giraudeau B, Rusch E. [Real-time contrast-enhanced ultrasound in the evaluation of focal liver lesions: diagnostic efficacy and economical issues from a French multicentric study]. J Radiol. 2009 Jan;90(1 Pt 2):109-22. doi: 10.1016/s0221-0363(09)70089-7. French.

  PMID: 19212279 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Michel CORREAS, Dr

  Necker Hospital

  PRINCIPAL INVESTIGATOR

• François TRANQUART, Pr

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 24, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: August 1, 2007
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (15)