Key Points
- A new clinical trial is investigating sonodynamic therapy for patients with recurrent glioblastoma.
- This is the first clinical trial in the US to use the NaviFUS device, which combines neuronavigation with a mobile, noninvasive focused ultrasound system.
The first participant received sonodynamic therapy (SDT) in a new clinical trial investigating the safety and feasibility of using SDT in patients with recurrent glioblastoma (GBM).
SDT is an emerging modality for cancer treatment that uses focused ultrasound to activate agents in tumor cells and cause cell death. In this pilot trial, a team of researchers at the University of Virginia (UVA) School of Medicine are using NaviFUS’s neuronavigation-guided focused ultrasound system to activate 5-aminolevulinic acid (5-ALA), an optical imaging agent that selectively accumulates in tumor cells and is commonly used to visualize tumors during surgery.
Up to 11 participants will receive 5-ALA orally approximately six hours before the noninvasive focused ultrasound procedure. This delay allows sufficient time for the agent to accumulate in the tumor cells. Researchers will use focused ultrasound to activate the 5-ALA in up to 50% of the tumor volume.
The trial is being led by UVA Health neurosurgeon Shayan Moosa, MD, and is being funded by the Focused Ultrasound Foundation.
“Despite all that we are able to offer with aggressive surgery, radiation, and chemotherapy, patients who are diagnosed with glioblastoma have an average life expectancy of only 15 months,” said Dr. Moosa. “This is why it is so important to investigate novel treatments, such as sonodynamic therapy, that may one day provide additional hope for patients who suffer from this horrible disease.”
This is the first clinical trial at the UVA School of Medicine, and the first in the nation, to use NaviFUS’s innovative device, which combines neuronavigation and a mobile, noninvasive focused ultrasound system. Unlike other focused ultrasound devices that are designed to treat the brain, the NaviFUS system does not require a frame attached to the skull, a large space, or an expensive MRI suite.
“Sonodynamic therapy has emerged as a promising treatment modality for cancer, and we are thrilled to support this clinical trial at UVA,” said Lauren Powlovich, MD, the Foundation’s associate chief medical officer. “We are also proud to have been a part of bringing this new focused ultrasound device to the University, and we hope it enhances the therapeutic armamentarium for patients with glioblastoma.”
Though this is the first trial exploring NaviFUS’s device for SDT, the company has completed clinical studies to open the blood-brain barrier for recurrent GBM and induce neuromodulation to reduce seizure frequency in patients with epilepsy.
For Patients
If you are interested in learning more about this trial (UVA IRB HSR230064), visit the clinicaltrials.gov page.