Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography

Inclusion Criteria:

Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration

*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).

Willing and able to provide informed consent

Exclusion Criteria:

Lesions located in the darkly pigmented nipple-areolar complex area
Subjects with breast implants
Abnormality in the mirror image location of the contralateral breast.
Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy
Previous breast irradiation of the mirror image location of the contralateral breast
Lesions located at previous biopsy sites when biopsy occurred within the last six months.
Small lesions of less than 1 cm located at skin or close to the skin
Pregnancy
Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin