This trial investigates how well a device called the Breast Cancer Locator (BCL) works in identifying the location of cancer in the breast in patients with ductal carcinoma in situ or invasive breast cancer that can be felt by touch (palpable). The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with patients lying flat on their back (just as in an operating room table). The BCL is then custom made for each patient using 3 dimensional (D) printing technology. If the BCL is able to accurately localize breast cancer, it may be a useful guide for surgeons for women non-palpable breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03573661.
PRIMARY OBJECTIVE:
I. To determine the proportion of patients who will have had the localization wire deployed within the cancer on the specimen mammogram.
SECONDARY OBJECTIVES:
I. To determine whether the study radiologist can accurately segment the tumor from the supine magnetic resonance imaging (MRI) images that are provided.
II. To determine time from supine MRI to delivery of the Breast Cancer Locator (BCL) to the surgeon.
III. To determine whether the BCL enabled the surgeon to successfully place all surgical cues in/on the breast (tumor edges, peripheral and central hook wire placement).
IV. To determine lumpectomy specimen volumes.
V. To determine operative times.
VI. To determine the pathologic tumor margins (distance from the tumor to the specimen edge).
VII. To determine complications from surgery.
VIII. To determine surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator.
OUTLINE:
Patients undergo surgical resection of the breast tumor with the BCL device.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorRichard J. Barth
