Multihance Versus Magnevist in Breast MRI

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

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