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