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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
71
BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening
University of California, Los Angeles
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Adverse Events
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE
Time frame: Through study completion, up to 1 year
Correlation with Tumor Tissue
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
Time frame: Up to 3 hours Post-BBBD
Circulating Free DNA
To demonstrate that there is at least a 2-fold increase in circulating free DNA following blood brain barrier disruption (BBBD)
Time frame: Up to 3 hours Post-BBBD
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University of California San Francisco
San Francisco, California, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Miami Cancer Institute at Baptist Health
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Maryland, Baltimore & The University of Maryland Medical System
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 7 more locations