Multihance Versus Magnevist in Breast MRI

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

To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Inclusion Criteria:

• Provides written informed consent
• Female
• Age 18 years or older
• Suspicious or known breast lesion based on results from mammography or ultrasound
• Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam

Exclusion Criteria:

• Body weight > 100 kg
• Pregnant or lactating
• Server or end-stage organ failure
• Moderate to severe renal impairment
• Undergoing radiotherapy or completed radiotherapy in the last 18 months
• Chemotherapy within 6 months of the 1st MRI exam