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    Research Grants Awarded

    Real-Time Imaging of Human Breast Tissue by Reflectance Confocal Microscopy

    Study Section:
    Detection, Diagnosis and Prognosis

    Scientific Abstract:
    There are currently no reliable methods by which to evaluate breast biopsy specimens or surgical margins of breast cancers in real-time. The absence of such a technology requires clinicians to collect multiple biopsies to obtain adequate tissue for evaluation. In addition, several days are required to process and review the specimens for content or margin status. The objective of this clinical translational project is to develop and test reflectance confocal microscopy (RCM) as a means of providing nondestructive pathology and a real-time assessment of biopsy material. The aims of this project are to determine: (1) if RCM can provide for an immediate evaluation of core biopsy tissue for percent cellular content and for non-malignant versus malignant breast tissue; (2) if RCM can identify chemotherapy-induced changes in cell viability and/or tissue remodeling on serial biopsy samples obtained during the course of neoadjuvant chemotherapy; (3) if RCM can be used to evaluate surgical specimens for non-malignant versus malignant breast tissue to establish an imaging equivalent of the histologically proven “clear surgical margin”; (4) if tissue imaged by RCM can be processed for ER a , PR, and ErbB2 immunohistochemistry (IHC) without a loss of diagnostic accuracy. The imaging aims are part of two ongoing clinical protocols. Subjects participating in one study consent to the collection of additional breast tissue samples at the time of their diagnostic biopsy or definitive breast surgery. Subjects participating in the other study consent to serial core needle biopsies of the breast primary at four time points during the course of neoadjuvant chemotherapy. Normal, preneoplastic, and neoplastic breast tissue will be obtained specifically for biomarker investigations, including examination by RCM, which is followed by routine H&E staining and IHC. When applicable, excisional breast tissue will be evaluated by RCM to assess the surgical margins in the operating room. We anticipate that completion of this project will validate the role of RCM in the management of breast cancer patients. Use of this technology will lead to a decrease in the number of core needle biopsy specimens needed for diagnosis, a decrease in the need for multiple re-excisions for involved surgical margins, and an improved ability to assess treatment responsiveness in patients receiving neoadjuvant chemotherapy without affecting the ability to conduct routine pathologic and IHC analyses.

    Lay Abstract:
    There are currently no reliable methods by which to immediately evaluate breast biopsy specimens or surgical margins of breast cancers. The absence of such a technology requires patients to undergo multiple biopsies in order to obtain adequate tissue for evaluation. In addition, several days are required to process and review the tissue specimens for content or margin status. The objective of this clinical translational project is to develop and test reflectance confocal microscopy (RCM) as a means of providing nondestructive pathology and a real-time assessment of biopsy material. The aims of this project are to determine: (1) if RCM can be used for an immediate evaluation of core biopsy tissue for the presence/absence of cancer; (2) if RCM can identify chemotherapy-induced changes in biopsy samples obtained during the course of preoperative chemotherapy; (3) if RCM can be used to evaluate surgical specimens for the presence/absence of cancer to establish an imaging equivalent of the “clear surgical margin”; (4) if tissue imaged by RCM can be processed to determine hormone receptor and ErbB2 status without a loss of diagnostic accuracy. The imaging aims are part of two ongoing clinical protocols. Subjects participating in one study consent to the collection of additional breast tissue samples at the time of their diagnostic biopsy or definitive breast surgery. Subjects participating in the other study consent to core needle biopsies of the breast tumor at four time points during the course of preoperative chemotherapy. Normal, precancerous, and cancerous breast tissue will be obtained specifically for research studies, including examination by RCM, which is followed by standard evaluations by a pathologist. When applicable, breast tissue removed during surgery will be evaluated by RCM to assess margin status in the operating room. We anticipate that completion of this project will validate the role of RCM in the management of breast cancer patients. Use of this technology will lead to a decrease in the number of core needle biopsy specimens needed for diagnosis, a decrease in the need for multiple operations for positive surgical margins, and an improved ability to assess treatment responsiveness in patients receiving preoperative chemotherapy without affecting the ability to conduct standard evaluations by a pathologist.