Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

Inclusion Criteria: * female * subject is 25-100 years of age * subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy * subject is able to provide informed consent Exclusion Criteria: * subject is pregnant * subject is actively lactating or discontinued breastfeeding less than 2 months ago * subject has breast implants * subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study * subject has contraindications for core biopsy and other invasive procedures * subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus * subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months * subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging