Focused Ultrasound for Brain Cancer

This trial tests a new method to treat brain cancer, specifically glioblastoma, by using focused ultrasound to temporarily open the blood-brain barrier. The goal is to determine if this approach, known as Focused Ultrasound Blood-Brain Barrier Disruption, is safe and feasible for individuals already receiving the standard chemotherapy treatment, temozolomide. Participants will undergo focused ultrasound sessions and imaging tests to assess the treatment's effectiveness. Individuals who have undergone glioblastoma surgery, are in the maintenance phase of their treatment, and have a clearly defined tumor on an MRI scan may be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

The trial does not specify if you need to stop all current medications, but you cannot be on certain treatments like bevacizumab or anti-coagulants close to the treatment time. It's best to discuss your specific medications with the trial team.

Research has shown that focused ultrasound (FUS) is a promising method to safely open the blood-brain barrier (BBB). This technique allows precise targeting of brain areas and enhances drug delivery to the brain. Studies have demonstrated that FUS can temporarily open the BBB, increasing treatment effectiveness.

FUS is considered safe because it is non-invasive and aids in delivering chemotherapy to brain tumors like glioblastoma. This method has been used for other conditions and is generally well-tolerated with few side effects. Early studies also suggest that low-intensity ultrasound can increase drug levels in the brain without major safety concerns.

Unlike the standard treatment for brain cancer, which typically relies on chemotherapy drugs like temozolomide (TMZ) alone, focused ultrasound blood-brain barrier (BBB) disruption offers a unique approach. This treatment uses the Next Generation Dome Helmet to send ultrasound waves that temporarily open the BBB, allowing better delivery of chemotherapy directly to the brain tumor. Researchers are excited about this technique because it enhances the effectiveness of existing drugs by improving their access to the tumor site, potentially increasing treatment efficacy and minimizing side effects.

Research shows that focused ultrasound (FUS) offers a promising way to safely open the blood-brain barrier (BBB). The BBB acts as a natural shield, preventing many treatments from reaching the brain. In this trial, participants will undergo FUS-mediated BBB disruption using the Next Generation Dome Helmet during the maintenance phase of standard-of-care temozolomide (TMZ) chemotherapy. Studies have found that FUS can help drugs reach brain tumors like glioblastoma by making the BBB more permeable. This non-invasive method, which doesn't require surgery, has been linked to improved delivery of chemotherapy drugs. Early evidence suggests that this technique could enhance the effectiveness of brain cancer treatments, potentially leading to better survival rates.¹²³⁴⁶