An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
Conditions
Breast Cancer
Conditions: Keywords
Partial Mastectomy, Lumpectomy, Mastectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 49-channel optical spectrometer
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Clinical diagnosis of Breast Cancer

Exclusion Criteria:
Location
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Start Date
May 2006
Completion Date
July 2015
Sponsors
Duke University
Source
Duke University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page