Rhode Island Hospital has launched the nation’s first clinical trial investigating the use of non-invasive focused ultrasound in combination with immunotherapy to treat brain metastases—marking a major milestone in the advancement of neuro-oncology care.

This groundbreaking study will evaluate the safety and efficacy of focused ultrasound technology as a potential alternative to conventional treatments such as surgery and radiation therapy, which can carry significant risks and side effects. By contrast, this clinical trial aims to determine whether focused ultrasound—a technique that uses sound waves to target tissue deep within the brain—can safely and more effectively treat metastatic tumors when paired with immunotherapy.

“Our laboratory research suggests this approach can significantly improve outcomes for patients with brain metastases,” said Dr. Clark C. Chen, professor of Neurosurgery and director of the Brain Tumor Program at Brown University Health. “We’re excited to lead this first-of-its-kind U.S. study and to offer patients a non-invasive option that could redefine how we treat brain tumors.”

The trial leverages a powerful combination: focused ultrasound to temporarily open the blood-brain barrier (BBB), and immunotherapy, a treatment that has already revolutionized outcomes for patients with advanced cancers, particularly lung cancer. The BBB, while protecting the brain from harmful substances, also blocks many anti-cancer therapies. By briefly disrupting this barrier, focused ultrasound allows immunotherapy drugs to reach brain tumors more directly and in greater concentrations.

This trial is being conducted in collaboration with leading U.S. medical institutions and sponsored by Insightec, a global leader in focused ultrasound technology. The research is supported by funding from the Rainwater Charitable Foundation, which also provided the clinical infrastructure enabling this innovative work.

For more information please visit: Study Details | Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets | ClinicalTrials.gov

Patients interested in participating in the study should contact Amanda Hasbrouck at 401-793-9177.

Jessica Wharton

Senior Public Relations Officer
401-525-8928
[email protected]