Breast Cancer
Conditions
Brief summary
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
Interventions
DRUGMultihance
0.5 Molar at a single dose injection
DRUGMagnevist
0.5M at a single dose injection
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity in diagnosing breast lesions compared to histopathology results | up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels | up to 6 months |
Countries
Italy
Outcome results
None listed