Multihance Versus Magnevist in Breast MRI
Phase 3
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00486473
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 130
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Sensitivity in diagnosing breast lesions compared to histopathology results up to 6 months
- Secondary Outcome Measures
Name Time Method Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels up to 6 months