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

This study is currently recruiting participants.
Verified June 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734955
First Posted: August 14, 2008
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Duke University
  Purpose
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: None (Open Label)
Primary Purpose: Device Feasibility
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 2018
Estimated Primary Completion Date: December 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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of Breast Cancer

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734955


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

Locations
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)
Investigators
Principal Investigator: Nimmi Ramanujam, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734955     History of Changes
Other Study ID Numbers: Pro00007857
1R01EB011574-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 13, 2008
First Posted: August 14, 2008
Last Update Posted: June 16, 2017
Last Verified: June 2017

Keywords provided by Duke University:
Partial Mastectomy
Lumpectomy
Mastectomy