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 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734955
First received: August 13, 2008
Last updated: August 15, 2014
Last verified: August 2014
  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: 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 ] [ Designated as safety issue: No ]
    The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.


Estimated Enrollment: 400
Study Start Date: May 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Nimmi Ramanujam, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734955     History of Changes
Other Study ID Numbers: Pro00007857, 1UL1 RR024128-01, W81XWH-09-1-0410
Study First Received: August 13, 2008
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Partial Mastectomy
Lumpectomy
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014