Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer

Inclusion Criteria:

Mass palpable or nonpalpable
Tissue density - all tissue types
Menses - any stage of cycle
Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion[s])
Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
Any tumor type (patients with inflammatory breast cancer may be included)

Exclusion Criteria:

Patient is unable or unwilling to give informed consent for any reason
Disability (psychiatric, neurological or physical, which precludes examination)
Patient has tattoos on the region of interest
Overweight over 250 pounds (LB)
Very large breast size exceeding 6 inch diameter
Patient has body piercing jewelry through the nipple that cannot be removed
Patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post biopsy [bx] change may be included)
Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast
Patient has any pain or high sensitivity in the breast
Currently taking hormonal replacement therapy
Non-ambulatory or unable to comply with exam
Pregnant (pregnancy test is not required, only as confirmed by patient)
Breastfeeding
Prior breast treatment for target lesion
Previous surgery of the breast in the last 3 months