A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery
Exclusion Criteria
- •patients who were diagnosed with excisional biopsy and patients undergoing mastectomy
Outcomes
Primary Outcomes
The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy.
Secondary Outcomes
- 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.
- Two potential benefits from developing this technology are:
- 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.