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Systems and Methods to Rapidly Survey the Morphological Landscape of Breast Tissue during Surgery

Brandon Nichols, PhD

Patients with stage I or II breast cancer are typically eligible for a surgical procedure known as breast conserving surgery (BCS). BCS involves removing the tumor and a thin peripheral layer or “margin” of disease-free tissue surrounding the tumor. Also known as a partial mastectomy or lumpectomy, BCS has been shown to be as effective as a total mastectomy when combined with radiation therapy and is therefore the more frequent surgical choice for patients with early stage breast cancer. The inability to detect malignant cells within the vicinity of the margin edge during surgery poses a significant unmet clinical need: the surgeon cannot definitively resolve the possibility of incomplete disease excision during the initial surgery, which may require the patient to return for an additional surgery due to increased risk in local recurrence of disease.
We have developed a portable, breast margin assessment probe (BMAP) that surgeons can use to quantify the morphological landscape of breast margins during surgery. The approach leverages a custom16-channel annular photodiode array, a raster-scanning imaging platform with precision pressure control, and compressive sensing with an optimized set of 8 wavelengths in the visible spectral range (λ = 470-600). A scalable Monte-Carlo forward model is used to generate a look-up table to invert sub-millimeter (0.75mm) resolution diffuse reflectance data, providing detailed optical parameter maps of excised breast tissue over an area of ~ 2x2 cm2 on intra-operative time scales (~ 8 minutes). Specifically, the relative amount of adipose to fibrous/glandular tissue, via the ratio of beta-carotene concentration to wavelength averaged µs’ is used infer the likelihood of disease. An empirical cumulative distribution function (eCDF) analysis is used to reduce optical property maps to quantitative distributions for statistical stratification of breast tissue subtypes. We believe the BMAP system is a pragmatic solution to the margin assessment problem: the portability, accuracy, and manufacturability provide a realistically translatable path for integration into the clinical standard of care.

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