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

The Washington University

Status

Completed

Conditions

Breast Biopsy

Treatments

Device: Hand-held hybrid probe

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03842358

1R01CA228047-01A1 (U.S. NIH Grant/Contract)

201707042

Details and patient eligibility

About

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.

Enrollment

298 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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