A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01372631
First received: June 12, 2011
Last updated: August 19, 2014
Last verified: August 2014
  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: Open Label
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:
  • Sensitivity and specificity of optical spectral imaging system [ Time Frame: Day of procedure (less than 10 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of the optical signatures of breast tissue [ Time Frame: Day of procedure (less than 10 minutes) ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nimmi Ramanujam, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01372631     History of Changes
Other Study ID Numbers: Pro00028284
Study First Received: June 12, 2011
Last Updated: August 19, 2014
Health Authority: United States: National Institutes of Health
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014