Clinical Trial 49933

Phoenix, AZ 85013


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.

  • 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)

Qualified Participants May Receive:

As part of a clinical trial at the Ivy Brain Tumor Center, the study drugs will be provided free of charge, however, the patient and/or their health plan/insurance company will be responsible for some or all of the costs of treating the tumor in the study, including any standard medical care such as surgical resection.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.