Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
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ClinicalTrials.gov Identifier: NCT00734838 |
Recruitment Status
:
Recruiting
First Posted
: August 14, 2008
Last Update Posted
: June 16, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Device: High Resolution Microendoscope | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 162 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 2018 |
Estimated Study Completion Date : | December 2018 |

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
|
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients having a needle biopsy of a breast mass
Exclusion Criteria:

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
Contact: Nimmi Ramanujam, Ph.D. | (919) 660-5307 |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27708 |
Principal Investigator: | Nimmi Ramanujam, PhD | Duke University |
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 ) |
First Posted: | August 14, 2008 Key Record Dates |
Last Update Posted: | June 16, 2017 |
Last Verified: | June 2017 |
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 |