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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07076472 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received radiation therapy.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages