NL-OMON30924
Completed
Phase 3
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast. - DETECT
Bracco-Byk0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- breastcancer
- Sponsor
- Bracco-Byk
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •written Informed Consent
- •Female subject of 18 years or older
- •At least one suspicious or known breast lesion
- •Is planned to undergo histological diagnosis of breast lesions
Exclusion Criteria
- •\-has body weight \> 100 Kg
- •\-is pregnant or lactating
- •\-has severe or end\-stage organ failure
- •\-has moderate to severe renal impairment
- •\-is undergoing or has undergone radiotherapy within 18 months before exam 1
- •\-is undergoing or has undergone chemotherapy/antitumural hormonal therapy within 6 months before exam 1
- •\-has recieved or scheduled to receive any onther contrast medium 24 hours before or after exam1
- •\-has history of breast surgery
Outcomes
Primary Outcomes
Not specified
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