Fast Spectral Imaging Device for Tumor Margin Mapping
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | September 2009 |
| End Date: | September 2011 |
| Contact: | Nimmi Ramanujam, PhD |
| Phone: | 919-660-5307 |
The objective of the proposed research is to develop a clinical-trial-ready device and to
evaluate its practical utility as a routinely used intra-operative tool. Our
multidisciplinary group has previously shown that optical techniques can effectively
discriminate between malignant and non-malignant breast tissues. The proposed technology
will be a multi-channel optical assay device for intra-operative imaging of margins in
specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or
mastectomy.
Inclusion Criteria:
- Patients undergoing a partial mastectomy or 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
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