Investigating 5-ALA + LIDU Sonodynamic Therapy for Glioblastoma

This study is testing a new treatment for newly diagnosed glioblastoma (a type of brain cancer) after standard surgery and chemoradiation. It combines an investigational drug called 5-Aminolevulinic Acid (5-ALA) with a non-invasive ultrasound device (Low Intensity Diffuse Ultrasound Sonodynamic Therapy System, or LIDU SDT). The goal is to see if this combination, along with standard temozolomide chemotherapy, can improve how long patients live without their cancer growing (progression-free survival). You would be randomly assigned to receive either the active 5-ALA + LIDU SDT or a placebo and a sham (inactive) ultrasound. This study is for people aged 18 to 80 with a good general health status. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 103 participants. Participants will be randomly assigned to one of two groups: active treatment or a placebo/sham group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, progression-free survival, will be measured for up to 24 months.

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NCT07225621

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Alpheus Medical, Inc.
~103 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:5-ALA HCl + LIDU SDTPlacebo + Sham SDT

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate and compare progression-free survival of patients by treatment arm
Measured over Up to 24 months
Glioblastoma
GBM
11 sites across 5 states
New York7
Massachusetts1
Minnesota1
Ohio1
Pennsylvania1
Ann-Marie VP, Clinical Operations
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  • Evaluate and compare progression-free survival of patients by treatment armUp to 24 months