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

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ClinicalTrials.gov Identifier: NCT00734955
Recruitment Status : Recruiting
First Posted : August 14, 2008
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: 49-channel optical spectrometer Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
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
Study Start Date : May 2006
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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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:


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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734955     History of Changes
Other Study ID Numbers: Pro00007857
1R01EB011574-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: June 2017

Keywords provided by Duke University:
Partial Mastectomy
Lumpectomy
Mastectomy