MRI-guided focused ultrasound with 5‑ALA for recurrent glioblastoma
Official title: Sonodynamic therapy using MRI-guided focused ultrasound in combination with 5-aminolevulinic acid to treat recurrent glioblastoma multiforme
Funded at Sonalasense INC · NIH-10813104 · Data updated 2026-11-12
This project uses a non-invasive MRI-guided focused ultrasound together with the drug 5‑ALA as a possible treatment for people with recurrent glioblastoma.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Sonalasense INC NIH-funded |
| Lab location | 1 site (Oakland, UNITED STATES) |
| Project start | April 1, 2023 |
| Project end | August 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $796,215 |
| NIH project number | 5R44CA275508-02 |
| Project ID | NIH-10813104 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are people with recurrent glioblastoma who can undergo MRI and MRgFUS, can take 5‑ALA, and have a targetable tumor region suitable for focused ultrasound.
✕Less likely to help
Patients with widespread multifocal disease, tumors too close to critical brain structures, contraindications to MRI or 5‑ALA (for example porphyria), or who cannot travel to a treatment center may not benefit from this approach.
What this research studies
You would take a drug called 5‑aminolevulinic acid (5‑ALA) that concentrates in tumor cells, then doctors use MRI-guided focused ultrasound (MRgFUS) to activate the drug inside the brain without heating surrounding tissue. Activation turns 5‑ALA into a light-sensitive molecule (PpIX) that produces reactive oxygen to kill tumor cells by necrosis and apoptosis. Animal studies showed tumor regression and longer survival, and an early Phase 0/1 human trial has shown feasibility. The work aims to develop this drug-device combination into a safe, targeted, non-invasive option for people with recurrent GBM.
Why it matters
Potential benefit: If successful, this approach could shrink recurrent tumors and extend survival while avoiding more invasive brain surgery or higher-dose radiation.
How similar studies have gone: Preclinical glioma models showed safety and tumor regression with ALA-activated MRgFUS, and a first-in-human Phase 0/1 trial demonstrated feasibility but larger controlled trials are still needed.
Where this research is happening
-
Sonalasense INC
Oakland, United States Active
Researchers
- Principal investigator: Marcus, Stuart — Sonalasense INC
- Study coordinator: Marcus, Stuart
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.