A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
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|ClinicalTrials.gov Identifier: NCT00243698|
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : November 22, 2007
Ultrasound is a well-established imaging modality for the evaluation of breast disease.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Tumors||Drug: SonoVue (sulphur hexafluoride microbubbles)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||May 2007|
- Drug: SonoVue (sulphur hexafluoride microbubbles)
One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
- From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements. [ Time Frame: Inclusion period ]
- Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples [ Time Frame: inclusion period ]
- Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only) [ Time Frame: inclusion period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243698
|University Hospital of Tours|
|Tours, France, 37044|
|Study Director:||François Tranquart, PR||Centre d'Innovation Technologique CHRU Tours|
|Principal Investigator:||Catherine LABBE, MD||CRLCC René Gauducheau 44805 ST HERBLAIN|