A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions|
- 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 ]
|Study Start Date:||May 2004|
|Study Completion Date:||May 2007|
Drug: SonoVue (sulphur hexafluoride microbubbles)
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: 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|