Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
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- STATUS
- Recruiting
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- days left to enroll
- 76
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- participants needed
- 50
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- sponsor
- InSightec
Julia Zhu
Primary Contact
Sunnybrook Health Sciences Centre (4.7 mi away) Contact
+3 other locationSummary
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
Description
This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.
Details
| Condition | Recurrent Glioblastoma |
|---|---|
| Treatment | carboplatin, ExAblate BBBD |
| Clinical Study Identifier | NCT04440358 |
| Sponsor | InSightec |
| Last Modified on | 15 December 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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