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| Name | Class |
|---|---|
| Cancer Prevention Research Institute of Texas | OTHER |
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This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WF-OCT imaging of excised breast lumpectomy tissue | Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational WF-OCT device | Device | Excised lumpectomy tissue will be imaged on an investigational WF-OCT device |
|
| Measure | Description | Time Frame |
|---|---|---|
| WF-OCT image acquisition of excised lumpectomy tissue margins | This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Consented patients meeting eligibility criteria, undergoing breast conservation surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Savitri Krishnamurthy, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| MD Anderson Cancer Center |
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| Houston |
| Texas |
| 77030 |
| United States |