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 Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy

This study is testing a new way to treat glioblastoma, a fast-growing brain tumor, using a special drug activated by sound waves. Researchers want to see if combining this new sound-wave therapy with standard chemotherapy helps fight the cancer better than chemotherapy alone.

You may be able to join if you are between 18 and 80 years old, can care for yourself, and have a newly diagnosed glioblastoma that was partially or mostly removed through surgery. You must have also already completed your initial radiation and chemotherapy.

Participants will be placed at random into one of two groups: one receiving the active drug and ultrasound therapy, and the other receiving an inactive placebo and fake ultrasound. Both groups will continue taking their standard chemotherapy medicine, and neither you nor your doctor will know which group you are in.

The study is currently recruiting patients at medical centers in Boston, Massachusetts; Rochester, Minnesota; and Albany, New York. It is a Phase 2 trial comparing the new treatment approach against standard care.