RecruitingEarly Phase 1NCT07076472

Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma

MC240704 Pilot Dose Escalation and Expansion Study of Sonodynamic Therapy With Aminolevulinic Acid Hydrochloride (5-ALA HCl Or SONALA-001) in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (RGBM)

Sponsor

Mayo Clinic

Enrollment

8 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Glioblastoma Progressive Glioblastoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called sonodynamic therapy — which combines a light-sensitive drug with focused ultrasound directed through the skull — in people with glioblastoma (a serious brain tumor) that has come back or kept growing after prior treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with recurrent or progressive glioblastoma (as defined by 2021 WHO criteria) - Surgery to remove the tumor is not currently an option for you - You have already received radiation therapy - Your overall health is adequate (ECOG score 0, 1, or 2) - You have a life expectancy of at least 12 weeks - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - Your blood counts (hemoglobin, white blood cells, platelets) are too low - Your liver function is significantly impaired - You are pregnant or breastfeeding - You cannot safely undergo the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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