Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
NCT04440358 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-01-20
Summary
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.
Conditions
Interventions
- DEVICE
-
Exablate BBBD
BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
- DRUG
-
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
Sponsors & Collaborators
-
InSightec
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-13
- Primary Completion
- 2023-11-30
- Completion
- 2023-12-31
Countries
- Canada
- Italy
- South Korea
Study Locations
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