A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
NCT ID: NCT00243698
Last Updated: 2007-11-22
Study Results
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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COMPLETED
NA
59 participants
INTERVENTIONAL
2004-05-31
2007-05-31
Brief Summary
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The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.
SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.
Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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SonoVue (sulphur hexafluoride microbubbles)
One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
Eligibility Criteria
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Inclusion Criteria
* Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
* Woman scheduled for biopsy or surgery within 1 month from the examination.
Exclusion Criteria
* Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
* Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
* Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
* Pregnant or nursing female
* Patient known to have a coronary syndrome
* Unstable angina and myocardial infarction
* Acute cardiac failure, Class III/IV cardiac failure
* Severe rhythm disorders
* Acute endocarditis
* Prosthetic valves
18 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Principal Investigators
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François Tranquart, PR
Role: STUDY_DIRECTOR
Centre d'Innovation Technologique CHRU Tours
Catherine LABBE, MD
Role: PRINCIPAL_INVESTIGATOR
CRLCC René Gauducheau 44805 ST HERBLAIN
Locations
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University Hospital of Tours
Tours, , France
Countries
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References
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Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. doi: 10.1016/j.ejrad.2004.04.017.
Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51. doi: 10.2325/jbcs.12.45.
Watermann D, Madjar H, Sauerbrei W, Hirt V, Prompeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.
Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.
Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. doi: 10.1148/radiology.189.1.8372225.
Other Identifiers
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CT03-FT/SEN
Identifier Type: -
Identifier Source: org_study_id