A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
Inclusion period
François Tranquart, PR
Study Director
Centre d'Innovation Technologique CHRU Tours
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CT03-FT/SEN
NCT00243698
May 2004
May 2007
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