Breast Cancer
Conditions
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.
Interventions
PROCEDUREfluorescence spectroscopy and diffuse spectroscopy
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed