Breast Cancer Clinical Trial
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Summary
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
Eligibility Criteria
Inclusion Criteria:
Women 18 years of age or older
Signed informed consent form
Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Exclusion Criteria:
Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
Neoadjuvant systemic therapy
All T4 tumors
Previous radiation in the operated breast
Prior surgical procedure in the same quadrant
Implants in the operated breast
Pregnancy
Lactation
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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