The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.
Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
≥ 18 and ≤ 80 years of age
WHO performance status of ≤ 2 at screening
Newly diagnosed Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.
Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)
Bihemispheric disease or tumors that involve the bilateral corpus callosum, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement,
Multi- centric disease (enhancing or non-enhancing) or multi-focal disease (defined as 2 separate areas of contrast enhancement measuring at least 1 cm that are not contiguous and cannot be encompassed in sonication field on either fluid-attenuated inversion recovery (FLAIR) or T2 hyperintensity.
Leptomeningeal disease
Parallel
5-ALA HCl + LIDU SDT
Combination productstandard of care temozolomide + sonosenitizer + sonodynamic therapy
Placebo + Sham SDT
Combination productstandard of care temozolomide + placebo + sham sonodynamic therapy
Evaluate and compare progression-free survival of patients by treatment arm
Evaluate and compare overall survival of patients by treatment arm
Key Secondary
Evaluate and compare survival at specific time points by treatment arm
Evaluate the number of participants with treatment-related adverse events as assessed by CTCAE by treatment arm
Evaluate time to next treatment for 5-ALA + LIDU SDT System
Identify and evaluate prognostic and predictive factors (e.g. MGMT, extent of resection) for PFS
Exploratory
Identify and evaluate prognostic and predictive factors (e.g. MGMT, extent of resection) for OS
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