Clinical Research Directory

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/or chemotherapeutic), but not required for study inclusion * Ability to understand and the willingness to sign a written informed consent document 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 two different 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 can influence 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 are otherwise not intact prior to imaging (device arm only) imaging