Estudio abierto, multicéntrico, en fase III, con lectura ciega de imágenes, para evaluar la eficacia y la seguridad de una única inyección intravenosa de 0,1 mmol / kg de peso corporal de gadobutrol 1,0 molar (Gadovist®) en pacientes con diagnóstico reciente de cáncer de mama referidos para resonancia magnética de mama, realzada con contraste An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI 1. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol frente a la MRM sin realzar. 2. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol más MRX frente a ...

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An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI The primary objectives of this study are to demonstrate: 1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM 2. Superiority of combined unenhanced and gadobutrol-en...

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