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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 November 2016 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: December 19, 2016
Last verified: November 2016
  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

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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Optical signatures [ Time Frame: Day of procedure (less than 10 minutes) ]
    The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast


Estimated Enrollment: 162
Study Start Date: January 2006
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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
Using core biopsy and reduction mammoplasty tissue
Placebo Comparator: Reduction mammoplasty
Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer
Device: High Resolution Microendoscope
Using core biopsy and reduction mammoplasty tissue

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients having a needle biopsy of a breast mass

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: 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734838     History of Changes
Other Study ID Numbers: Pro00008003
NIH 5R01-CA-100559
W81XWH-09-1-0410 ( Other Grant/Funding Number: Department of Defense )
Study First Received: August 13, 2008
Last Updated: December 19, 2016

Keywords provided by Duke University:
Breast Cancer
Breast Biopsy
Reduction mammoplasty

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

ClinicalTrials.gov processed this record on March 22, 2017