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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 ...

Update Il y a 4 ans
Reference: EUCTR2009-009597-27

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

Woman and Man

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Extract

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-enhanced MRM plus XRM versus unenhanced MRM plus XRM Based on the categorical accuracy in determination of the extent of malignant breast disease on breast region level with 3 categories (unifocal, multifocal malignant disease or no malignant disease present) and verified by the predefined SoT (histopathology or alternatively XRM plus ultrasound)

Inclusion criteria

  • Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM

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