NCT07225621

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Alpheus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.

Conditions

• Glioblastoma
• GBM

Interventions

Type	Name	Description
COMBINATION_PRODUCT	5-ALA HCl + LIDU SDT	standard of care temozolomide + sonosenitizer + sonodynamic therapy
COMBINATION_PRODUCT	Placebo + Sham SDT	standard of care temozolomide + placebo + sham sonodynamic therapy

Timeline

• Start date: 2026-01-28
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-11-06
• Last updated: 2026-03-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study