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The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.
The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound (FUS) BBB Disruption | The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance guided Focused ultrasound (MRgFUS) | Device | FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets. |
| Measure | Description | Time Frame |
|---|---|---|
| Device and procedure related adverse events | The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE | Throughout the study, approximately 12 months. |
| Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging | The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging. | At the time of each ExAblate MRgFUS procedure] |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Neurologico Carlo Besta | Milan | 20133 | Italy | |||
| CINAC-Hospital HM Puerta del Sur |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| Móstoles |
| Madrid |
| 28938 |
| Spain |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |