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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EB011574-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction Mammoplasty | Experimental | Patients undergoing reduction mammoplasty |
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| Mastectomy | Experimental | Patients undergoing mastectomy |
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| Lumpectomy | Experimental | Patients undergoing a lumpectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 49-channel optical spectrometer | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the optical signatures of breast tissue. | The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue. | Day of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nimmi Ramanujam, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |