Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

Inclusion Criteria:

• Female

• Age 18 years or older

• Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ

• May include subjects treated with neo-adjuvant therapy (endocrine and/orchemotherapeutic), but not required for study inclusion

• Ability to understand and the willingness to sign a written informed consentdocument

Exclusion Criteria:

• Male

• Metastatic cancer (Stage IV)

• Lobular carcinoma as primary diagnosis

• Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation)

• Subjects with multi-centric disease (histologically diagnosed cancer in twodifferent quadrants of the breast), unless resected in a single specimen

• Subjects with bilateral disease (diagnosed cancer in both breasts)

• Participating in any other investigational margin assessment study which caninfluence collection of valid data under this study

• Use of cryo-assisted localization

• Currently lactating

• Current pregnancy

• Subjects for whom the specimen margins have been destroyed, damaged, or areotherwise not intact prior to imaging (device arm only) imaging