Lead Sponsor

Hologic, Inc.

Age

25 - No limit years

Sex

FEMALE

Healthy Volunteers

No

•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

•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).

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