A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/7/2018
Start Date:April 2011
End Date:December 2018
Contact:Nimmi Ramanujam, Ph.D.
Email:nimmi@duke.edu
Phone:919-660-5703

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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.

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.

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.
We found this trial at
2
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Nimmi Ramanujam, Ph.D.
Phone: 919-660-5307
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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mi
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Durham, NC
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Lee G Wilke, MD
Phone: 608-263-1387
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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mi
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Madison, WI
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