Computed Optical Margin Assessment for Breast Cancer Surgery

Inclusion Criteria:

1. Women 18 years of age or older

2. Signed informed consent form

3. Women who have been histologically diagnosed with invasive ductal carcinoma or
invasive lobular carcinoma of the breast prior to surgery

4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy)
procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of
the breast)

2. Neoadjuvant systemic therapy

3. All T4 tumors

4. Previous radiation in the operated breast

5. Prior surgical procedure in the same quadrant

6. Implants in the operated breast

7. Pregnancy

8. Lactation

9. Participating in any other investigational study for either drug or device which can
influence collection of valid data under this study