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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005567-27 | EudraCT Number |
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| Name | Class |
|---|---|
| National Competence Services for Ultrasound and Image-guided Therapy | UNKNOWN |
| SINTEF Health Research | OTHER |
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Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.
Ultrasound is currently used as a tool for providing 2D or 3D images for the purpose of tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond, potentially masking small tumor remnants and generally making the interpretation of images more difficult.
This research group has developed an acoustic fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. The investigators expect that the acoustic fluid will make it easier to detect small tumor remnants near the end of an operation, thus increasing success of glioma surgery. The purpose of this study is to test the fluid during surgery for histopathologically proven glioblastoma to assess safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMG | Experimental | brain mimicking fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brain mimicking fluid | Biological | filled into the operation cavity during surgery for glioblastoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | All adverse events registered but with special emphasis on: Intraoperatively -- epileptic seizures Immidiate postoperative -- hydrocephalus (MR images), imflammation of tissue that was in contact with AF (MR images) | 1-72 hours |
| adverse events | All adverse events registered but with special emphasis on: hydrocephalus (MR images) inflammation (MR images) | 1 month |
| adverse events | All adverse events registered but with special emphasis on: hydrocephalus (MR images), inflammation (MR images) | 6 months |
| adverse events | All adverse events registered but with special emphasis on: unusual clinical events, neurological deterioration or reduced consciousness | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| image quality | during the operation
| 1 day |
| image signal-to-noise ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir BrĂ¥then, phd md | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, St Olavs Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)
| 1 day |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |