NCT00243698

A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Tumors

Interventions

Type	Name	Description
DRUG	SonoVue (sulphur hexafluoride microbubbles)	One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)

Timeline

• Start date: 2004-05-01
• Completion: 2007-05-01
• First posted: 2005-10-24
• Last updated: 2007-11-22

Locations

1 site across 1 country: France