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| Name | Class |
|---|---|
| Brainlab AG | INDUSTRY |
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Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective arm | Experimental | Use of 3D ultrasound intraoperative before intraoperative MRI |
|
| retrospective matched pair arm | No Intervention | no use of intraoperative ultrasound before intraoperative MRI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resection with help of 3D ultrasound | Device | see above |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of resection | Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively. | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| image quality | ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst). | during surgery |
| neurological outcome | both at discharge and at 3 months follow up using NIHSS Score |
| Measure | Description | Time Frame |
|---|---|---|
| brainshift during surgery | brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI | during surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Coburger, apl. Prof. Dr. med. | Contact | 0822196 | 28858 | jan.coburger@uni-ulm.de |
| Christian R Wirtz, Prof. Dr. med. | Contact | 0822196 | 0 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tübingen | Recruiting | Tübingen | Baden Würtemberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36135087 | Result | Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518. |
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| ID | Term |
|---|---|
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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retrospective matched pair control
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| both after surgery and at 3 months |
| Accuracy of device | ultrasound image acuracy compared to preoperative MRI, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst), including rating of brainshift and navigation inaccuracy. | during surgery |
| University of Ulm | Recruiting | Ulm | Germany |
|