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Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

Not Applicable
Completed
Conditions
Breast Cancer
Registration Number
NCT00214292
Lead Sponsor
University of Wisconsin, Madison
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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