search
Back to results

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

Primary Purpose

Focal Liver Lesions, Liver Cancer, Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Real-time contrast-enhanced ultrasound sonography
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focal Liver Lesions focused on measuring focal liver lesions, contrast-enhanced ultrasound sonography, cirrhosis, suspected liver metastases, suspected liver cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU d'ANGERS
  • Hôpital Saint-Jacques, CHRU Besancon
  • Hôpital Saint-André, CHRU Bordeaux
  • Hôpital Beaujon, Assistance Publique Hôpitaux de Paris
  • Hospices Civils de Lyon
  • Hôpital Saint-Eloi, CHRU Montpellier
  • Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
  • Hôpital Necker, Assistance Publique Hôpitaux de Paris
  • Hôpital La Milétrie, CHRU Poitiers
  • Hôpital Robert Debré, CHRU Reims
  • Hôpital Nord, CHRU Saint-Etienne
  • Hôpital Bretonneau, CHRU Tours
  • Service de Radiologie, Hôpital d'Enfants de Brabois
  • Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Medical and economic interest of CEUS

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2005
Last Updated
March 18, 2008
Sponsor
University Hospital, Tours
Collaborators
Ministry of Health, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00243633
Brief Title
Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)
Official Title
Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Tours
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Liver Lesions, Liver Cancer, Liver Cirrhosis
Keywords
focal liver lesions, contrast-enhanced ultrasound sonography, cirrhosis, suspected liver metastases, suspected liver cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
878 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Real-time contrast-enhanced ultrasound sonography
Primary Outcome Measure Information:
Title
Medical and economic interest of CEUS
Secondary Outcome Measure Information:
Title
Method acceptability
Title
Contrast-enhanced ultrasound sonography tolerance
Title
Harmony inter-readers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Michel CORREAS, Dr
Organizational Affiliation
Necker Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François TRANQUART, Pr
Organizational Affiliation
University Hospital, Tours
Official's Role
Study Director
Facility Information:
Facility Name
CHRU d'ANGERS
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Saint-Jacques, CHRU Besancon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Hôpital Saint-André, CHRU Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital Beaujon, Assistance Publique Hôpitaux de Paris
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital Saint-Eloi, CHRU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Necker, Assistance Publique Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hôpital La Milétrie, CHRU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hôpital Robert Debré, CHRU Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Nord, CHRU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital Bretonneau, CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Service de Radiologie, Hôpital d'Enfants de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11179618
Citation
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.
Results Reference
background
PubMed Identifier
12649417
Citation
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.
Results Reference
background
PubMed Identifier
12594549
Citation
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.
Results Reference
background
PubMed Identifier
12817311
Citation
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.
Results Reference
background
PubMed Identifier
11861092
Citation
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.
Results Reference
background
PubMed Identifier
11861094
Citation
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.
Results Reference
background
PubMed Identifier
15238869
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs