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A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

This study is currently recruiting participants.
Verified November 2016 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372631
First Posted: June 14, 2011
Last Update Posted: June 20, 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.
Collaborators:
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Breast Cancer Device: miniature spectral imaging system Device: Bench-top optical spectrometer Device: High resolution microendoscope

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Identification of the optical signatures in breast tissue [ Time Frame: Day of procedure (less than 10 minutes) ]

Secondary Outcome Measures:
  • Sensitivity and Specificity of the device [ Time Frame: Day of procedure (less than 10 minutes) ]

Estimated Enrollment: 210
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pressure assessment
30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Experimental: Random and Systematic Errors
40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Experimental: Sensitivity and Specificity Assessment
150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Device: High resolution microendoscope
Use of high resolution microendoscope

Detailed Description:
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.
  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:   No
Criteria

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 document.

Exclusion Criteria:

  • Patients considered in "vulnerable" populations.
  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): NCT01372631


Contacts
Contact: Nimmi Ramanujam, Ph.D. 919-660-5703 nimmi@duke.edu
Contact: Marlee Krieger, M.S. 919-660-8446 marlee.krieger@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27708
Contact: Nimmi Ramanujam, Ph.D.    919-660-5307    nimmi@duke.edu   
Principal Investigator: Nimmi Ramanujam, Ph.D.         
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 54706
Contact: Lee G Wilke, MD    608-263-1387    wilke@surgery.wisc.edu   
Contact: Amanda Schulman    608 265-1113    Schulman@surgery.wisc.edu   
Principal Investigator: Lee G Wilke, MD         
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Principal Investigator: Nimmi Ramanujam, Ph.D. Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01372631     History of Changes
Other Study ID Numbers: Pro00028284
5R01EB011574 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2011
First Posted: June 14, 2011
Last Update Posted: June 20, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Duke University:
Reduction mammoplasty
mastectomy
partial mastectomy
lumpectomy
breast conserving surgery
breast cancer

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