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

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

Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.

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.
• Pregnancy
• Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin