The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.
Study Type
OBSERVATIONAL
Enrollment
54
Duke University Medical Center
Durham, North Carolina, United States
To perform a critical evaluation of the device in a practical clinical setting
(1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.
Time frame: 2 years
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