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A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

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

Exclusion Criteria:

- Patients considered in "vulnerable" populations.

Type of Study:


Study Design:


Outcome Measure:

Sensitivity and specificity of optical spectral imaging system

Outcome Time Frame:

Day of procedure (less than 10 minutes)

Safety Issue:


Principal Investigator

Nimmi Ramanujam, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: National Institutes of Health

Study ID:




Start Date:

April 2011

Completion Date:

April 2016

Related Keywords:

  • Breast Cancer
  • Reduction mammoplasty
  • mastectomy
  • partial mastectomy
  • lumpectomy
  • breast conserving surgery
  • breast cancer
  • Breast Neoplasms



Duke University Medical Center Durham, North Carolina  27710