A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
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Purpose
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins |
| Estimated Enrollment: | 210 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing a reduction mammoplasty or patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy
Inclusion Criteria:
- Patients undergoing a reduction mammoplasty
- Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy
- Age > 18
- Clinically detectable disease either by physical examination or radiographic studies
- Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients considered in "vulnerable" populations.
Contacts and Locations| Contact: Nimmi Ramanujam, Ph.D. | 919-660-5703 | nimmi@duke.edu |
| Contact: Marlee Junker, M.S. | 919-660-8446 | marlee.junker@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27708 | |
| Contact: Nimmi Ramanujam, Ph.D. 919-660-5307 nimmi@duke.edu | |
| Principal Investigator: Nimmi Ramanujam, Ph.D. | |
| Principal Investigator: | Nimmi Ramanujam, Ph.D. | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01372631 History of Changes |
| Other Study ID Numbers: | Pro00028284 |
| Study First Received: | June 12, 2011 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: National Institutes of Health |
Keywords provided by Duke University:
|
Reduction mammoplasty mastectomy partial mastectomy |
lumpectomy breast conserving surgery breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013