Breast Tumors Clinical Trial
Official title:
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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