Contrast-Enhanced MRI of the supra-aortic vessels The primary efficacy evaluation will be based on three primary efficacy variables: • Assessability • Sensitivity • Specificity which will be calculated for both gadobutrol-enhanced MRA and non-co...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Safety of Gadovist® in Renally Impaired Patients The primary objective is to assess the magnitude of potential risk with the administration of Gadovist in patients with moderate to severe renal impairment for the development of NSF, based on diagnos...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

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 ...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

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...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune