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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 01 mmolkg body weight of gadobutrol 10 molar Gadovist in patients with newly diagnosed...

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

FieldValue
Modified
2020-07-22
Release Date
2019-07-22
Identifier
05578ff8-7f73-4ff3-bc00-cf53c0763281
License
License Not Specified
Public Access Level
Public