RecruitingPhase IIEN originalGlioma (brain cancer)

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 18 do 80 lat
  • Nowo rozpoznany glejak mózgu potwierddzony badaniem histologicznym
  • Przeprowadzona wcześniej operacja usunięcia guza (nie sama biopsja)
  • Ukończona chemioterapia i radioterapia bez objawów progresji choroby
  • Liczba trombocytów co najmniej 50 000 komórek na mm³
  • Prawidłowa funkcja wątroby i nerek
  • Kobieta: w okresie menopauzalnym, bezpłodna chirurgicznie lub stosująca skuteczną antykoncepcję
  • Chęć udziału i zrozumienie badania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
80 Years
Last updated (source)
July 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (11)

Dana Farber Cancer Institute

Boston, United States

Mayo Clinic

Rochester, United States

Albany Medical Center

Albany, United States

Dent Neurologic Institute

Buffalo, United States

Northwell Health

Long Island City, United States

New York Langone

New York, United States

Columbia University

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

University of Rochester

Rochester, United States

Ohio State University

Columbus, United States

Penn State Milton S. Hershey Medical Center

Hershey, United States

Trial contact

Ann-Marie VP, Clinical Operations

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/18/2026.

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