The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0, first-in-human clinical trial of sonodynamic therapy (SDT) in ascending energy doses to assess safety and efficacy in patients with recurrent high-grade glioma.
In this study, sonodynamic therapy is the combination of the drug SONALA-001 (5-ALA, aminolevulinic acid HCl, or ALA) and a Magnetic Resonance-Guided Focused Ultrasound device called the Exablate 4000 Type-2 Device.
The goal of this study is to assess biological changes (tumor cell death) associated with the sonodynamic therapy.
Criteria:- You are 18 years or older
- You have had prior resection (surgical removal) of a histologically diagnosed high-grade glioma (III and IV)
- You have been treated with radiation and a chemotherapy drug called temozolomide
- Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed)