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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734838
First received: August 13, 2008
Last updated: October 6, 2014
Last verified: October 2014
History of Changes
  Purpose

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.


Condition Intervention
Breast Cancer
 Device: High Resolution Microendoscope
Device: Bench-top optical spectrometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Optical signatures [ Time Frame: Day of procedure (less than 10 minutes) ] [ Designated as safety issue: No ]
    The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast
Estimated Enrollment: 377
Study Start Date: January 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Core needle biopsy
Patients needing a needle biopsy of a breast mass
 Device: High Resolution Microendoscope Device: Bench-top optical spectrometer

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

Inclusion Criteria:

  • Patients having a needle biopsy of a breast mass

Exclusion Criteria:

  • none
  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: NCT00734838

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
William Marsh Rice University
Investigators
Principal Investigator: Nimmi Ramanujam, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734838     History of Changes
Other Study ID Numbers: Pro00008003, NIH 5R01-CA-100559, W81XWH-09-1-0410
Study First Received: August 13, 2008
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Breast Cancer
Breast Biopsy
Simple Mastectomy
Partial Mastectomy

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

ClinicalTrials.gov processed this record on February 27, 2015