SBIR-STTR Award

Each year, over 700 women undergo an image-guided core needle biopsy (CNB) to evaluate a suspicious breast finding at the Seattle Cancer Care Alliance, with only about 30% biopsies yielding malignancy. Typical turnaround time for determination of the presence or absence of cancer from CNBs is three to five business days, and this waiting time can lead to avoidable anxiety and delays in management. Our team has pioneered the use of open-top light-sheet microscopy (OTLS), which is a slide-free fluorescence imaging technique that enables rapid, large area scanning of fresh tissue. A preliminary study using excised 1 cm2 pieces of fresh breast tissue showed that OTLS imaging can provide diagnostic quality images in under 10 minutes. We hypothesize that OTLS evaluation of CNB breast tissue specimens will provide an accurate determination of malignancy vs. no malignancy within 30 minutes of obtaining breast core specimens. We will test this hypothesis by optimizing evaluation of CNB samples with OTLS using breast cancers that have been excised surgically and then testing its accuracy in a small clinical trial of 40 women. If successful, our approach could allow women with concerning breast imaging findings to have a complete imaging and pathology workup in the same day, leading to reassurance in the majority of women and earlier triage to appropriate care in those with breast cancer. Furthermore, wider application of this technology could allow for more accurate whole-specimen evaluation of biomarkers of disease, such as quantification of tumor infiltrating lymphocytes, and more elegant radiology-pathology correlation studies that could advance the emerging fields of radiomics and pathomics. Public Health Relevance Statement Narrative Breast cancer is common, accounting for approximately 40,000 deaths among U.S. women each year. The current chain of events for diagnosing breast cancer (screening, diagnostic mammography, biopsy, and pathology) can require weeks, causing avoidable anxiety and delays in treatment for women with breast cancer. We propose workflow, aided by novel open- top light-sheet microscopy, for same day end-to-end breast cancer diagnostics.

Project Terms:
Accounting ; Anxiety ; Biopsy ; Breast ; malignant breast neoplasm ; Breast Cancer ; malignant breast tumor ; Malignant Neoplasms ; Cancers ; Malignant Tumor ; malignancy ; neoplasm/cancer ; Clinical Trials ; Communication ; Correlation Studies ; Statistical Correlation ; Cessation of life ; Death ; Diagnosis ; Diagnostic Imaging ; Disease ; Disorder ; Frozen Sections ; Freeze Sectioning ; Frustration ; Gold ; Health ; Holidays ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Light ; Photoradiation ; Mammography ; Mammogram ; mammographic Imaging ; mammographic examinations ; mammographic exams ; Mastectomy ; Mammectomy ; Microscopy ; Persons ; Pathology ; Patients ; Personal Satisfaction ; well-being ; wellbeing ; Physical Examination ; Medical Inspection ; Radiology Specialty ; General Radiology ; Radiology ; Stains ; Staining method ; Technology ; Telephone ; Phone ; Testing ; Thinness ; Leanness ; Time ; Tissues ; Body Tissues ; Transportation ; Triage ; Ultrasonography ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; Woman ; Imaging Techniques ; Imaging Procedures ; Imaging Technics ; Tumor-Infiltrating Lymphocytes ; Paraffin Embedding ; Businesses ; Schedule ; Blinded ; Caring ; improved ; Site ; Area ; Benign ; Clinical ; Malignant - descriptor ; Malignant ; Ensure ; Evaluation ; Lesion ; Letters ; clinical Diagnosis ; Pathologist ; Diagnostic ; Research Specimen ; Specimen ; Event ; Scanning ; Clinic ; Slide ; Image Guided Biopsy ; H and E ; Hematoxylin and Eosin ; Hematoxylin and Eosin Staining Method ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Histopathology ; Biopsy Sample ; Biopsy Specimen ; novel ; Categories ; Reporting ; Emotional ; Limited Resection Mastectomy ; Local Excision Mastectomy ; Lumpectomy ; breast lumpectomy ; Sampling ; cancer care ; cancer diagnosis ; breast cancer diagnosis ; Formalin ; Provider ; Tissue Sample ; preventing ; prevent ; Core Needle Biopsy ; Core Biopsy ; Address ; Breast cancer screening ; Breast screening ; mammary cancer detection ; mammary screening ; Breast Cancer Detection ; Detection ; Cancer Diagnostics ; Calendar ; research clinical testing ; Clinical Evaluation ; Clinical Testing ; clinical test ; Enrollment ; enroll ; Screening Result ; Fresh Tissue ; Pathologic ; Mammary Gland Parenchyma ; Breast Tissue ; Mammary Gland Tissue ; Preparation ; Process ; sample fixation ; Fixation ; Image ; imaging ; fluorescence imaging ; fluorescent imaging ; screening ; breast imaging ; mammary imaging ; image guided ; image guidance ; microscopic imaging ; microscope imaging ; microscopy imaging ; radiomics ; biomarker evaluation ; marker evaluation ; clinical imaging ; Wait Time ; breast pathology ;