A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
Breast Cancer
About this trial
This is an interventional device feasibility trial for Breast Cancer focused on measuring Reduction mammoplasty, mastectomy, partial mastectomy, lumpectomy, breast conserving surgery, breast cancer
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
- University of Wisconsin - Madison
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Pressure assessment
Random and Systematic Errors
Sensitivity and Specificity Assessment
30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.