An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
- Conditions
- Breast Cancer
- Registration Number
- NCT00734955
- Lead Sponsor
- Duke University
- Brief Summary
Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
- Clinical diagnosis of Breast Cancer
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Identification of the optical signatures of breast tissue. Day of procedure The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Duke University Medical Center🇺🇸Durham, North Carolina, United States