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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
This study is currently recruiting participants.
Verified June 2017 by Duke University
Sponsor:
Duke University
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734838
First received: August 13, 2008
Last updated: June 15, 2017
Last verified: June 2017
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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: None (Open Label) Primary Purpose: Device Feasibility |
| 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
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: | June 15, 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 |
ClinicalTrials.gov processed this record on September 21, 2017