Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.

A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.

Inclusion Criteria:

• Female
• Age 18 years or older
• Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
• May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Metastatic cancer (Stage IV)
• Lobular carcinoma as primary diagnosis