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

trialsTrialRecruiting

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

A phase 2 trial of Aminolevulinic acid (topical, for photodynamic therapy) in glioma & glioblastoma, run by Alpheus Medical, Inc., now recruiting.

Overview Connected3

Overview

Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma is a phase 2 interventional study registered as NCT07225621 by Alpheus Medical, Inc., with 103 participants planned, started 2026-01-28 and due to reach its primary completion in 2027-12. Interventions recorded: 5-ALA HCl + LIDU SDT and Placebo + Sham SDT.

Setting

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

Phase

Phase 2

Sponsor

Alpheus Medical, Inc.

Registry

Started

2026-01-28

Enrolled

103 enrolled

Connected

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cancers

Glioma & glioblastoma

technologies

Thermal ablation and cryotherapy for cervical precancer

drugs

ApprovedTopical porphyrin precursor for photodynamic therapy

Aminolevulinic acid (topical, for photodynamic therapy) · Levulan Kerastick / Ameluz

Evidence strength30/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2+15
103 enrolled+10
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT07225621

Data

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Cancers

Glioma & glioblastoma

Technologies

Thermal ablation and cryotherapy for cervical precancer

Products

Aminolevulinic acid (topical, for photodynamic therapy)

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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