RecruitingPhase 2NCT07225621

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


Sponsor

Alpheus Medical, Inc.

Enrollment

103 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a low-intensity ultrasound device (a type of sound wave therapy) to the standard post-surgery chemotherapy regimen for people with newly diagnosed glioblastoma (an aggressive brain tumor) improves survival. The ultrasound is delivered through a wearable device and is meant to disrupt tumor cell division. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with glioblastoma confirmed by biopsy (WHO 2021 criteria, without IDH mutation) - You have already undergone tumor removal surgery and completed the standard combination of radiation and chemotherapy (temozolomide) - Your cancer has not progressed since completing chemoradiation - You are in reasonably good health and your blood counts and organ function are adequate **You may NOT be eligible if...** - You only had a biopsy (not actual tumor removal surgery) - You did not complete at least 90% of your planned radiation and 66% of your chemotherapy doses - You still have significant side effects from your chemoradiation that have not resolved - You are pregnant or breastfeeding - You have an active serious infection or other condition that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCT5-ALA HCl + LIDU SDT

standard of care temozolomide + sonosenitizer + sonodynamic therapy

COMBINATION_PRODUCTPlacebo + Sham SDT

standard of care temozolomide + placebo + sham sonodynamic therapy


Locations(8)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Albany Medical Center

Albany, New York, United States

Dent Neurologic Institute

Buffalo, New York, United States

Northwell Health

Long Island City, New York, United States

New York Langone

New York, New York, United States

Columbia University

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07225621


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