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    Awarded Grants
    A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In-Situ of the Breast

    Scientific Abstract:
    Many patients with ductal DCIS are candidates for breast conserving therapy. The most important predictor of local recurrence after breast conserving therapy with radiation is pathologic margin status, but reported rates of re-excision to clear close or positive surgical margins range between 48% and 59%. Intraoperative frozen section and touch prep cytology are used to assess surgical margins and guide additional resection at the time of surgery. These techniques are time consuming and require specially trained personnel. Fluorescence spectroscopy is an optical method that can rapidly differentiate between tumor and normal tissue in a variety of epithelial organ systems. Fluorescent biological molecules (fluorophores) in tissue illuminated with specific wavelengths of ultraviolet or visible light, absorb energy and emit it as fluorescent light. Diffuse reflectance spectroscopy provides direct measurement of light absorption as well as scattering. Fluorophores can be endogenous to the tissue or exogenous in the form of an injectable fluorescent molecule. Exogenous fluorophores have known photophysical and pharmacokinetic properties and are highly fluorescent. However, potential drug toxicity and timing of administration are of concern. Endogenous fluorophores include amino acids, structural proteins, enzymes and co-enzymes, vitamins, lipids and porphyrins. Previously, our group demonstrated an ex vivo sensitivity and specificity of 70 and 91.7% using optical techniques to differente tumor from benign breast tissue. This study will apply optical spectroscopy to intraoperative margin assessment during surgery for DCIS. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results. This innovative, minimally invasive technology has the potential to provide a rapid diagnostic tool for surgical margin assessment during breast cancer surgery.

    Lay Abstract:
    Improved mammographic screening has led to an increase in the number of ductal carcinoma in situ (DCIS) cases diagnosed each year. Breast conserving surgery is appropriate therapy for many of these women. Achieving complete removal of all tumor cells with a rim of normal tissue surrounding them (the surgical margin) is crucial to successful surgery with a low recurrence rate. Many women undergo additional surgery in order to clear the surgical margins of tumor that may remain after the initial surgery. Intraoperative techniques for detecting involved margins and guiding additional tissue removal are time consuming and require specially trained personnel. Fluorescence spectroscopy is an optical method that can rapidly differentiate between tumor and normal tissue. When tissue is illuminated with specific wavelengths of light (excitation), fluorescent biological molecules (fluorophores) absorb the energy and release it as fluorescent light at longer wavelengths (emission). Diffuse reflectance spectroscopy is another optical method that directly measures light absorption and scattering by tissues. Previous work by our group demonstrated that fluorescence spectroscopy and diffuse reflectance have promising sensitivity and specificity for differentiating invasive breast cancer from benign breast tissue, and in the current study we will exploit the differences in optical properties between normal breast tissue and ductal carcinoma in-situ. This study proposes to apply optical spectroscopy to margin assessment during surgery for localized ductal carcinoma in-situ. Twenty patients with ductal carcinoma in-situ will be recruited. Breast conserving surgery will be carried out according to standard procedure, and the surgical site will be scanned with a sterile optical spectroscopy probe. Frozen sections from the medial, lateral, inferior, superior, and deep aspects of the surgical cavity will then be submitted for analysis. Optical spectroscopy measurements will then be categorized as benign or malignant using a statistical algorithm and the results compared with the frozen and section results. This innovative, minimally invasive technology has the potential to provide a reproducible, rapid intraoperative diagnostic tool for the assessment and management of surgical margins during breast cancer surgery.