This Phase II trial tests if sonodynamic therapy (SDT)-a non-invasive treatment using ultrasound to activate a cancer-killing drug-improves outcomes for newly diagnosed glioblastoma patients.
Who? 230 adults (\<75 years) with confirmed glioblastoma, adequate organ function, no major health issues.
Groups:
Test Group: SDT + standard therapy (radiation, chemo, bevacizumab). Control Group: Standard therapy alone.
Procedure:
SDT uses the drug Hiporfin® followed by focused ultrasound sessions. Patients avoid sunlight for 1 month.
Study Duration:
Treatment: \~6-8 weeks. Follow-up: 24 months (monthly MRIs).
Key Goal:
Compare progression-free survival (time until tumor worsens) between groups. Secondary goals: overall survival, safety.