Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast

INTERVENTION: In Exam 1, 50 % of the patients start with MultiHance, the others with Magnevist. In Exam 2 the patients get the other contrast liquid in comparison with Exam 1. CONDITION: ; breastcancer ; mammacarcinoma 10006291 PRIMARY OUTCOME: Diagnostic performance of MULTIHANCE and MAGNEVIST will be evaluated by ; comparing the off‐site evaluation results of MRI with the truth standard ; findings. Sensitivity, specificity, accuracy, positive predictive value and ; negative predictive value of breast MRI performed with MULTIHANCE or MAGNEVIST ; will be analyzed independently against the truth standard findings at lesion, ; region, breast and subject levels. The primary endpoint of this study will be ; sensitivity with the hypothesis of superiority of MULTIHANCE over MAGNEVIST for ; breast MRI in the diagnosis of breast cancer. Only lesions confirmed as ; malignant by histopathology will contribute to the primary analysis. ; SECONDARY OUTCOME: Measures of diagnostic performance for each MRI examination will also be ; calculated at region, breast and subject levels and compared as secondary ; endpoints. ; INCLUSION CRITERIA: written Informed Consent Female subject of 18 years or older At least one suspicious or known breast lesion Is planned to undergo histological diagnosis of breast lesions