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| ID | Type | Description | Link |
|---|---|---|---|
| NIH 5R01-CA-100559 | |||
| W81XWH-09-1-0410 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| William Marsh Rice University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core needle biopsy | Experimental | Patients needing a needle biopsy of a breast mass |
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| Reduction mammoplasty | Placebo Comparator | Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Resolution Microendoscope | Device | Using core biopsy and reduction mammoplasty tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| Optical signatures | The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast | Day of procedure (less than 10 minutes) |
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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 |