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This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferometric Synthetic Aperture Microscopy | Device | Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With All Positive/Close Margins Correctly Identified With the Device | 1 week after surgery | |
| Number of Margins With False Positive Device Readings | 1 week after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Women with breast cancer undergoing lumpectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Jacobs | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | 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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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |