Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Laser Interstitial Thermal Therapy
Radiation therapy and temozolomide
Washington University
St Louis, Missouri, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Adverse Events
Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
Time frame: 2 Years
Progression-Free Survival Rate
To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
Time frame: 2 Years
Overall Survival
To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System
Time frame: 2 Years
Changes in Quality of Life
Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools
Time frame: 2 Years
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