Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In

This is a research study that includes studying 5-Aminolevulinic Acid (5-ALA) combined with a Low-Intensity Diffuse Ultrasound (LIDU) system for Sonodynamic Therapy (SDT) in patients with newly diagnosed glioblastoma. The purpose of this study is to assess if standard of care maintenance temozolomide combined with 5-ALA and SDT is better than standard of care temozolomide combined with placebo, an oral solution that will look like and taste like 5-ALA but will have no active ingredients in it, and sham SDT, a program will be run on the SDT device that will look and sound the same, but will not deliver ultrasound. The SDT tested in this study includes the oral drug 5-Aminolevulinic Acid (5-ALA) as an investigational sonosensitizer. Sonosensitizers are a type of drug that are sound- sensitive that when activated by ultrasound waves may cause damage to cancer cells. This investigational treatment is being tested as a potential treatment for glioblastoma. SDT has been shown in previous cell and animal studies to potentially have an anti-cancer effect. 'Investigational' means the device being tested has not been approved by the United States Food and Drug Administration (FDA).

Are you Eligible? (Inclusion Criteria)

• Must be between the ages of 18 and 80 (inclusive) - Have a confirmed diagnosis of newly diagnosed glioblastoma - Cannot be pregnant or trying to become pregnant