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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 10 to 11v9
  2. Site contacts updated at 3 of 10 sitesv8
  3. Study sites: 9 to 10v7
  4. Study sites: 8 to 9v6
  5. Study sites: 3 to 8v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Jan 2026 to Jan 28, 2026v4
  2. Study sites: 2 to 3v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date: Dec 2025 to Jan 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date: Dec 2025 to Jan 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07225621
Lead Sponsor Alpheus Medical, Inc.
Conditions Glioblastoma, GBM
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov