Taiwan-based focused ultrasound manufacturer NaviFUS recently announced the start of its first clinical trial for glioblastoma. To date, three patients have been treated. Researchers at Chang Gung Memorial Hospital are investigating focused ultrasound to induce opening of the blood-brain barrier (BBB) in patients with glioblastoma using optically guided, neuronavigational technology. The safety and feasibility study uses the company's proprietary system to noninvasively treat these deadly cancers.
Led by neurosurgeon Kuo-Chen Wei, MD, the dose-escalating feasibility study will evaluate the safety of focal BBB opening with focused ultrasound plus microbubbles using neuronavigational guidance plus CT/MR image treatment planning. Six patients with recurrent glioblastoma multiforme (GBM) who plan to undergo tumor debulking surgery will be enrolled. The first two patients enrolled in August 2018 passed Data Safety Materials Board review, and the third patient was treated in late October with a higher level of focused ultrasound energy.
"The goal of the study is to investigate the possibility for treating recurrent GBM patients with focused ultrasound technology " said NaviFUS Chief Executive Officer Arthur Lung, PhD. "This is the first step in meeting the goal of our company, which is launching our neuronavigational system into the therapeutic market."
The safety evaluation of the focused ultrasound treatment, which includes MRI imaging and clinical evaluation, will be done immediately after the procedure and again one day later. Furthermore, the researchers will also use dynamic contrast-enhanced MRI to evaluate the effectiveness of BBB opening. Patients will have three follow-up visits before and after their planned tumor debulking surgery.
"The NaviFUS system is exceptionally innovative," says Foundation Chairman Neal F. Kassell, MD. " Focused ultrasound has been proven to open the blood-brain barrier, but studies to date have used MR-guidance. If successful, this clinical trial will be transformative and widen the market for neurological applications of focused ultrasound."
NaviFUS also has plans to begin a clinical trial for patients with epilepsy and expand the treatment envelope to include areas of the brain that have thus far been unreachable by focused ultrasound.
For more information on enrolling patients in the study, contact:
Kuo-Chen Wei, MD, via telephone at 886-3-3281200 ext 2412, or via emailat