A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
Conditions
Breast Cancer
Conditions: Keywords
Reduction mammoplasty, mastectomy, partial mastectomy, lumpectomy, breast conserving surgery, breast cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: miniature spectral imaging system Type: Device
Name: Bench-top optical spectrometer Type: Device
Name: High resolution microendoscope Type: Device
Overall Status
Recruiting
Summary
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
Detailed Description
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients undergoing a reduction mammoplasty OR

- Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy

- Age > 18

- Clinically detectable disease either by physical examination or radiographic studies

- Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Patients considered in "vulnerable" populations.
Location
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Nimmi Ramanujam, Ph.D. - 919-660-5307 - nimmi@duke.edu
Start Date
April 2011
Completion Date
April 2016
Sponsors
Duke University
Source
Duke University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page