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| ID | Type | Description | Link |
|---|---|---|---|
| BRN0044 | Other Identifier | OnCore | |
| IRB-48092 | Other Identifier | Stanford IRB |
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The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.
Primary Objective:
The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.
Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging
-To describe the ability of the CONVIVO imaging system to generate readable images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convivo Imaging | Experimental | The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONVIVO Confocal Endomicroscopy System | Device | Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon | Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning | Time for tissue visualization with CONVIVO system: defined as the total number of minutes from start of imaging device use to mock diagnosis. This is calculated by summing the number of minutes from the start of imaging device use to the end of imaging device use in the operating room and the number of minutes from the neuropathologist's start of image review to arrival at a mock diagnosis. Time for standard cryosectioning: defined as the total number of minutes required for standard cryosectioning. This is calculated by summing the number of minutes from when the operating surgeon contacts the neuropathology department to request a frozen section analysis of tissue and ends when the neuropathology department calls the operating room with a suspected diagnosis, as measured by study personnel present in the operating room during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
* Patients with any kind of contraindication to the use of fluorescein
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Li | Stanford Universiy | Principal Investigator |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 12 months |
| Ability of the CONVIVO system capture a readable image | A readable image is defined as an image from which a neuropathologist can make a mock diagnosis. This will be reported as a number without dispersion. | 12 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |