- A new clinical trial will combine focused ultrasound and radiotherapy in patients with primary brain tumors.
- Studies suggest that opening the blood-brain barrier to enhance oxygenation of brain tissue could make radiotherapy more effective.
- The Foundation is funding this trial, which is expected to begin in Taiwan in September.
Taiwan-based manufacturer NaviFUS has announced it will begin a new clinical trial using its focused ultrasound therapy system to temporarily open the blood-brain barrier (BBB) as a way to increase efficacy of radiotherapy in patients with primary brain tumors.
Radiotherapy is a standard-of-care therapy for these patients, but research suggests that reduced blood flow and oxygen concentration in the tumor area inhibits the efficacy of radiotherapy. NaviFUS has conducted preclinical studies that suggest disrupting the BBB using their focused ultrasound system significantly increases the oxygen content of brain tissue, which – when combined with radiotherapy – can increase the tumor-inhibiting effect of the therapy. Results of these studies were presented at the Foundation’s 7th International Symposium on Focused Ultrasound. The upcoming clinical trial aims to confirm these results in humans.
This trial will evaluate the safety and preliminary efficacy of the combination treatment of focused ultrasound BBB opening and radiotherapy for recurrent gliomas. Eligible patients will have undergone traditional treatment, including surgery to remove the tumor and radiation, but experienced recurrence of the tumor.
The trial of six patients will take place at Linkou Chang Gung Memorial Hospital in Taiwan and is expected to enroll the first patient next month.
Unlike other focused ultrasound devices that use real-time MR technology to guide brain treatments, the NaviFUS® System uses neuronavigation and prior patient CT/MR images to direct the focused ultrasound energy. The device also includes a real-time acoustic emission/reflection monitoring function that can personalize a safe and optimal level of focused ultrasound energy treatment for each patient.
NaviFUS is also conducting another clinical trial at Linkou Chang Gung Memorial Hospital investigating the feasibility, safety, and preliminary efficacy of focused ultrasound to open the BBB and facilitate the delivery of the chemotherapy drug bevacizumab in patients with recurrent glioblastoma.
“If these two noninvasive focused ultrasound treatments for brain tumors can be successfully developed, they will improve upon previous brain cancer treatments by improving efficacy and minimizing treatment side effects,” says NaviFUS CEO, Arthur Lung, PhD.
Both studies are being supported by the Focused Ultrasound Foundation.