Randomized Study of Temozolomide With or Without 5-Aminolevulinic Acid and Low Intensity Ultrasound Therapy for Newly Diagnosed Glioblastoma After Chemoradiation

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with newly diagnosed glioblastoma, a type of brain tumor. This study compares the use of an investigational drug called 5-aminolevulinic acid 5-ALA combined with a non-invasive ultrasound device LIDU against a placebo and sham ultrasound procedure. All participants will continue to receive the standard oral chemotherapy drug Temozolomide following surgery and radiation treatment. The goal is to understand if the combination of 5-ALA and ultrasound improves outcomes compared to standard care alone. Participants will be randomly assigned to one of two groups one receiving the active study drug 5-ALA orally six to eight hours before a 40-minute session with the LIDU ultrasound device, followed by standard Temozolomide therapy the other receiving a placebo oral solution and a sham ultrasound procedure, also followed by Temozolomide. The ultrasound device will either be active or inactive, but neither the participants nor the investigators will know which group they are in. Treatment with Temozolomide will begin shortly after the ultrasound sessions according to approved dosing schedules. Throughout the study, participants will be monitored for progression-free survival, overall survival, and treatment-related side effects for up to 24 months. Evaluations include regular clinical assessments, imaging, laboratory tests, and recording any adverse events. The study aims to assess how long patients survive without tumor progression and to compare outcomes between the two treatment groups. Participants may be followed for up to two years after starting treatment to gather this information.

Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma