Skip to main content
Clinical Trials/NCT00734955
NCT00734955
Completed
Not Applicable

An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Duke University1 site in 1 country485 target enrollmentMay 2006
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Duke University
Enrollment
485
Locations
1
Primary Endpoint
Identification of the optical signatures of breast tissue.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
July 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Breast Cancer

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Identification of the optical signatures of breast tissue.

Time Frame: Day of procedure

The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

Study Sites (1)

Loading locations...

Similar Trials