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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003025-42 | EudraCT Number |
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because the study had to be redesigned and restarted as clinical device study
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| Name | Class |
|---|---|
| Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy | UNKNOWN |
| SINTEF Health Research | OTHER |
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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 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. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult.
This research group has developed an acoustic coupling 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. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High grade gliomas stage 1 ACF | Experimental | In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group. |
|
| Low-high grade gliomas stage 2 ACF | Experimental | If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma |
|
| High grade gliomas stage 1 control | Active Comparator | In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group. |
|
| Low-high grade gliomas stage 2 control | Active Comparator | If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acoustic coupling fluid | Biological | ultrasound images obtained with both ACF and Ringer's acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in serious adverse event rates (test minus control) | Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin | 72 hours |
| difference in serious adverse event rates (test minus control) | Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin | 30 days |
| difference in serious adverse event rates (test minus control) | Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| image artefacts | during the operation; Qualitative score of ultrasound image quality (poor-medium-good) | 1 day |
| image artefacts | during the operation; Qualitative score of artefacts in ultrasound images (none-some-much) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | assessed by EQ5D (generic) | 1 month |
| Quality of Life | assessed by QLQ-C30 (cancer specific) | 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petter Aadahl, 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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| ID | Term |
|---|---|
| C028570 | Ringer's acetate |
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|
| Ringer's acetate | Biological | ultrasound images obtained with Ringer's acetate only |
|
| 1 day |
| depiction of outline of the anatomy surrounding the resection cavity | during the operation; Qualitative score of ultrasound image quality (poor-medium-good) | 1 day |
| depiction of outline of the anatomy surrounding the resection cavity | during the operation; Qualitative score of artefacts in ultrasound images (none-some-much) | 1 day |
| image signal-to-noise ratio | after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR) | 1 day |
| Quality of Life | assessed by EQ5D (generic) | 6 months |
| Quality of Life | assessed by QLQ-C30 (cancer specific) | 6 months |
| 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 |