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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00734838
Recruitment Status : Suspended (COVID-19)
First Posted : August 14, 2008
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: High Resolution Microendoscope Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
Study Start Date : January 2006
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


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

Inclusion Criteria:

  • Patients having a needle biopsy of a breast mass

Exclusion Criteria:

  • none
Contacts and Locations
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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): NCT00734838


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
William Marsh Rice University
Investigators
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Principal Investigator: Nimmi Ramanujam, PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734838    
Other Study ID Numbers: Pro00008003
NIH 5R01-CA-100559
W81XWH-09-1-0410 ( Other Grant/Funding Number: Department of Defense )
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Keywords provided by Duke University:
Breast Cancer
Breast Biopsy
Reduction mammoplasty
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases