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Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma

A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 30 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).

Status
Open and enrolling subjects.
Location
Phoenix, Arizona
Total Participants
24
Primary Sponsor
Nader Sanai, MD
Additional Sponsor(s)
Barrow Neurological Institute
Ivy Brain Tumor Center
SonALAsense
InSightec