Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study

Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study

This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.

Inclusion Criteria:

• Subject is a female of any race and ethnicity.
• Subject is at least 25 years old
• Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
• Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
• >50% of the biopsied cancer mass must remain following biopsy OR
• A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy

Exclusion Criteria:

• Subject is unable or unwilling to undergo informed consent
• Subject has breast implant in the breast to be imaged
• Subject is pregnant
• Subject is breast feeding or lactating
• Subject has a known allergy to gadolinium contrast agents.
• Subject has a contraindication for MRI.
• Subject suspected to be at risk to complication from the contrast agents.
• Subject has a documented renal insufficiency,
• Subject requires renal dialysis.
• Subject has had a prior reaction to iodinated contrast.
• Subject has had a prior episode of anaphylactic reaction to any substance.
• Subject has taken metformin (Glucophage) within 48 hours of study procedures.
• Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).