Clinical Trials

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 (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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/6/23. Questions regarding updates should be directed to the study team contact.