A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

The goal of this research is to further develop novel optical assay systems for intra
operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are
seeking to establish the accuracy of first and second-generation prototypes of technologies
utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or
mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate
the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients,
(2) to assess random and systematic errors of the new miniature system on mastectomy
specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the
miniature spectral imaging system for margin assessment on excised partial mastectomy or
mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Inclusion Criteria:

- Patients undergoing a reduction mammoplasty OR

- Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or
non-invasive breast malignancy

- Age > 18

- Clinically detectable disease either by physical examination or radiographic studies

- Patients of all ethnic and gender groups will be included. Protocol accrual will be
reviewed annually to include a determination of minority and gender representation. If
accrual demonstrates under-representation of any group with comparison to disease
incidence in that group, appropriate measures will be undertaken to increase
participation of patients of that minority or gender group

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Patients considered in "vulnerable" populations.