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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Duke University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Duke University Identifier:
First received: August 13, 2008
Last updated: August 1, 2016
Last verified: August 2016
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.

Condition Intervention
Breast Cancer
Device: 49-channel optical spectrometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 530
Study Start Date: May 2006
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduction Mammoplasty
Patients undergoing reduction mammoplasty
Device: 49-channel optical spectrometer
Experimental: Mastectomy
Patients undergoing mastectomy
Device: 49-channel optical spectrometer
Experimental: Lumpectomy
Patients undergoing a lumpectomy
Device: 49-channel optical spectrometer


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinical diagnosis of Breast Cancer

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00734955

Contact: Nimmi Ramanujam, Ph.D. (919) 660-5307

United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Principal Investigator: Nimmi Ramanujam, PhD Duke University
  More Information

Responsible Party: Duke University Identifier: NCT00734955     History of Changes
Other Study ID Numbers: Pro00007857
1R01EB011574-01A1 ( US NIH Grant/Contract Award Number )
R01EB011574-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: August 13, 2008
Last Updated: August 1, 2016

Keywords provided by Duke University:
Partial Mastectomy
Mastectomy processed this record on April 28, 2017