Statement: Women who have undergone a breast enlargement procedure, and have since had the implants removed, are excluded from the primary trial.
Primary_evidence: 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