OncoMatch/Clinical Trials/NCT04559685
Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma
Is NCT04559685 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) and MR-Guided Focused Ultrasound device (MRgFUS) for high grade glioma.
Treatment: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · MR-Guided Focused Ultrasound device (MRgFUS) — A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT unmethylated
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
participants who have progressed on or following standard therapy as determined by the investigator
Cannot have received: investigational drug
Treatment with another investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcL; Platelets ≥100,000/mcL; hemoglobin ≥8.0 g/dL
Kidney function
Serum creatinine ≤1.5 X ULN
Liver function
total bilirubin ≤1.5 X ULN (≤2.0 X ULN for Gilbert's syndrome); AST(SGOT) ≤3 X ULN; ALT(SGPT) ≤3 X ULN; GGT ≤3 X ULN
Adequate bone marrow and organ function as defined by the following laboratory values...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
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