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

 -  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