A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioblastoma
- Sponsor
- InSightec
- Enrollment
- 71
- Locations
- 17
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors
Detailed Description
This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
- •Subjects with stereotactically-targetable suspected new or recurrent glioblastoma tumor on pre-operative brain imaging scans
- •Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care
- •Karnofsky Performance Score \>70
- •Able to communicate sensations during the Exablate BBBD procedure
Exclusion Criteria
- •Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
- •Multifocal tumors
- •Tumor morphology or other imaging findings that precludes the ability to sonicate the tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
- •MRI or clinical findings of:
- •Active or chronic infection(s) or inflammatory processes
- •Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages
- •Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
- •MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
- •Significant cardiac disease or unstable hemodynamic status
- •Documented myocardial infarction within six months of enrollment
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Through study completion, up to 1 year
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE
Correlation with Tumor Tissue
Time Frame: Up to 3 hours Post-BBBD
To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD
Secondary Outcomes
- Circulating Free DNA(Up to 3 hours Post-BBBD)