LumaMed LLC proposes developing "LumaScan", an innovative, cost effective and easy to use device for visualizing tumor margins during Breast Conservation Surgery (BCS), a method that is used in about 60-70% percent of breast cancer surgeries. Currently, breast tumors are approximately located using methods such as MRI or CT in a preoperative procedure. During surgery, however, there are no practical tools available that can accurately locate tumor margins or verify that the excised tissue lump has negative margins and the surgeon has to wait for histopathology results which can take several days. In 10 to 60% of BCS cases histopathology finds additional tumor at the margin. This situation results in repeat surgeries with the accompanied higher treatment cost, greater morbidity, infection risk, delayed adjuvant therapy, poor cosmetic outcomes and a patient's loss of confidence in the surgeon and wondering "why didn't you get it all?" LumaScan is based on Polarization Subtraction Imaging (PSI), a patented method that images the visible and near IR fluorescence and reflectance from superficial layers of the excised tissue in real time providing wide field, high resolution, and high contrast image guidance to the surgeon conducting a BCS surgical procedure in a practical, easy to use device. The wide field imaging allows a more comprehensive examination of the tissue surface, the high resolution approaches that of microscopic pathology and the high contrast permits the surgeon to assess tumor margins without the assistance of a pathologist. We aim to build clinical prototypes of LumaScan and test them in a clinical study of 40 subjects representing a wide range of breast cancer types. We further aim to show that the surgeon's ability to visualize cancer margins in the surgical suite using LumaScan is equal to that of a pathologist based on final histopathology images.
Public Health Relevance Statement: Public Health Relevance: LumaMed's proposed product will improve outcomes and reduce costs in a variety of cancer surgeries, most notably lumpectomies for breast cancer removal. Present technologies fail to allow complete removal of breast cancer in up to 60% of lumpectomy surgeries necessitating costly follow on procedures. Once available, LumaMed should be able to save several thousand dollars per patient on average and reduce morbidity, reduce mortality and improve cosmesis for breast cancer patients electing lumpectomy.
Project Terms: Address; Adjuvant Therapy; Adopted; Adoption; Affect; Anesthesia procedures; Applications Grants; base; Beds; Breast; breast lumpectomy; Cancer Etiology; Cancer Patient; cancer recurrence; cancer surgery; cancer type; Cancerous; Cause of Death; Cessation of life; Characteristics; Clinical; Clinical Research; Consultations; Cosmetics; cost; cost effective; Data; design; Devices; Diagnosis; Diagnostic radiologic examination; digital; digital imaging; Distant; Dyes; Evaluation; Excision; FDA approved; Feeling; Fluorescence; Fright; Frozen Sections; Future; Gold; Head and Neck Cancer; Healthcare; Heart Diseases; Hematoxylin and Eosin Staining Method; High-Risk Cancer; Histopathology; Hospitals; Hour; human subject; Image; Image Analysis; Imagery; imaging modality; Imaging technology; improved; in vivo; Infection; innovation; intraoperative imaging; Legal patent; Lesion; Light; Lung; Magnetic Resonance Imaging; Mainstreaming (Education); malignant breast neoplasm; malignant mouth neoplasm; Malignant neoplasm of brain; Malignant Neoplasms; Mammary Neoplasms; Marketing; Mastectomy; Methods; Metric; Microscopic; Morbidity - disease rate; Mortality Vital Statistics; Nature; Newly Diagnosed; Nonionizing Radiation; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Optics; Organ; Outcome; Pathologist; Pathology; Patients; Performance; Phase; Pilot Projects; Preoperative Procedure; prevent; Procedures; prototype; public health relevance; Quality of life; Repeat Surgery; Resolution; Risk; Security; Site; Skin Cancer; Specimen; Stream; Surface; Surgeon; Surgical margins; Survival Rate; Technology; Testing; Time; Tissue Preservation; Tissues; tool; Touch sensation; Training; Treatment Cost; tumor; Ultrasonography; Visible Radiation; Woman
