OncoMatch/Clinical Trials/NCT07076472
Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma
Is NCT07076472 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Aminolevulinic Acid Intravenous Formulation SONALA-001 and Oral Aminolevulinic Acid Hydrochloride for progressive glioblastoma.
Treatment: Aminolevulinic Acid Intravenous Formulation SONALA-001 · Oral Aminolevulinic Acid Hydrochloride — This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy
Previous treatment with radiotherapy (RT)
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Albumin ≥ 3 g/dL
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3; Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Albumin ≥ 3 g/dL; Potassium ≥ LLN; Serum total calcium ≥ LLN; Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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