Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Sensitivity in diagnosing breast lesions compared to histopathology results
Outcome Time Frame:
up to 6 months
Safety Issue:
No
Principal Investigator
Gianpaolo Pirovano, MD
Investigator Role:
Study Director
Investigator Affiliation:
Bracco Dianostics, Inc.
Authority:
Italy: Ethics Committee
Study ID:
MH 131
NCT ID:
NCT00486473
Start Date:
July 2007
Completion Date:
December 2009
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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