Trials / Completed
CompletedNCT04998864
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients
Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3 (actual)
- Sponsor
- InSightec · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magnetic Resonance guided Focused ultrasound (MRgFUS) | FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets. |
Timeline
- Start date
- 2021-08-25
- Primary completion
- 2023-07-27
- Completion
- 2023-10-12
- First posted
- 2021-08-10
- Last updated
- 2026-04-16
Locations
2 sites across 2 countries: Italy, Spain
Source: ClinicalTrials.gov record NCT04998864. Inclusion in this directory is not an endorsement.