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Protocol No. UW17092

Principal Investigator Wilke, Lee

Phase Pilot/Feasibility

Age Group Adult

Scope Local

Sponsor Type Industry

Title Intraoperative use of the OTIS (Optical Tissue Imaging System) in Surgically Excised Lumpectomy Breast Tissue

Objective The purpose of this research study is to evaluate the ability of a new device called the Optical Tissue Imaging System(OTIS) to determine the borders between normal and abnormal breast tissue removed during breast lumpectomy surgery. OTIS uses light in much the same way that sound is used to produce an image with ultrasound, instead using optical coherence tomography("OCT"). The researchers will be using OTIS to examine the tissue specimens after they are removed from your breast. There will be no action taken regarding your care related to this OTIS imaging results and images or information obtained from the device will not be used in decision-making for your breast surgery.

Treatment If you decide to participate in this study, tissue will be removed from your breast as it normally would during your lumpectomy surgery. This tissue will then be imaged in the operating room using the OTIS device, and imaged again after the standard of care x-ray imaging of the tissue is conducted. The margins between the normal and abnormal breast tissue will be assessed in each fresh lumpectomy specimen. Any margin area identified as suspicious by trained surgical personnel will be marked on the specimen and brought to the attention of the pathologist. Pathology will then examine and evaluate the tissue specimen using standard of care methods. There will be NO action taken regarding patient care related to the OTIS imaging results. Images or information obtained from the device will not be used in surgical decision-making.

Description Intraoperative use of the OTIS(Optical tissue imaging system) in surgically excised lumpectomy breast tissue

Key Eligibility
  • Female age 18 or older
  • Stage 0-III invasive ductal breast carcinoma and/or ductal carcinoma in situ
  • Patients undergoing elective breast conservation surgery for the treatment of IDC and/or DCIS of the breast
  • Ability to understand and the willingness to sign a written informed consent document
  • No male
  • No stage IV breast cancer
  • No lobular carcinoma as primary diagnosis
  • Can not be participating in another study that prolongs time to pathologic processing (greater than 1 hour) No prior neo-adjuvant treated patients (with any chemotherapeutic or endocrine therapy)
  • No eligibie if a surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon¬ís intraoperative decision will not be used in the data analysis of this study. These subjects will not be replaced in the study but the surgeon's intraoperative decision to conduct a frozen section analysis will be disclosed in any final summary.)
  • No prior use of cryosurgery
  • Can not be currently lactating
  • Can not be pregnancy
  • No previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics