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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

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 16 Apr 2026

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At a glance

  • Drugs Aminolevulinic acid (Primary) ; Antineoplastics
  • Indications Glioblastoma
  • Focus Therapeutic Use
  • Sponsors Alpheus Medical

Most Recent Events

  • 09 Apr 2026 According to Alpheus Medical media release, the company announced the initiation of its Phase 2b randomized controlled trial in newly diagnosed glioblastoma (nGBM) with 10 patients enrolled to date and additional clinical sites continuing to come online.
  • 13 Jan 2026 Planned initiation date changed from 1 Dec 2025 to 1 Jan 2026.
  • 13 Jan 2026 Status changed from not yet recruiting to recruiting.

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