Rhode Island Hospital has launched the nation's first clinical trial combining focused ultrasound technology with immunotherapy to treat brain metastases, marking a significant advancement in neuro-oncology care for patients with advanced cancer.
The groundbreaking study targets patients with non-small cell lung cancer that has spread to the brain, a condition known as brain metastases that affects an estimated one in four lung cancer patients. Dr. Clark Chen, a brain surgeon at Brown University Health who helped design the clinical trial, emphasized the urgent need for new treatment approaches.
"We are the first in the United States to enroll the patient," said Chen, who serves as professor of Neurosurgery and director of the Brain Tumor Program at Brown University Health. "It's estimated that over 98% of the drugs that we have today cannot get in to the brain and as a result we have very limited options in the treatment of brain cancer."
Overcoming the Blood-Brain Barrier Challenge
The primary obstacle in treating brain metastases lies in the blood-brain barrier, a protective shield that prevents most therapeutic agents from reaching brain tumors. This natural defense mechanism, while protecting healthy brain tissue, severely limits treatment options for patients whose cancer has spread to the brain.
Brain metastases represent the most common type of brain tumor in adults, occurring far more frequently than primary brain cancers like glioblastoma. These secondary tumors typically originate from cancers in other parts of the body, including lung, breast, or melanoma.
Innovative Treatment Approach
The new clinical trial employs focused ultrasound technology that uses sound waves to target tissue deep within the brain. The non-invasive procedure works by converging ultrasound waves through a specialized cap to a single spot in the brain using MRI guidance.
"Very much like when you take a magnifying glass you can focus all the sunbeams on to a single spot. This equipment's designed so that all the ultrasounds can converge in a single spot and that spot then receives enough energy to open up the blood brain barrier," Chen explained.
The treatment protocol involves administering focused ultrasound first to temporarily open the blood-brain barrier, followed by immunotherapy infusion. "We'll do the ultrasound first to open up the blood brain barrier and then the patient is moved, taken to the infusion center where they get the drug and then the drug better penetrates the tumor," Chen said.
Trial Design and Global Scope
The randomized clinical trial will compare two treatment approaches: participants will be randomly assigned to receive either immunotherapy alone or the combination of focused ultrasound plus immunotherapy. The treatment regimen consists of six treatments administered three weeks apart.
Chen noted that earlier research has shown promising results. "Our laboratory research suggests this approach can significantly improve outcomes for patients with brain metastases," he said. "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 study represents a collaborative effort involving seven institutions worldwide, with Rhode Island Hospital serving as the lead enrollment site. The trial is sponsored by Insightec, a global developer of focused ultrasound technology, and supported by the Rainwater Charitable Foundation, which provided funding and clinical infrastructure.
Broader Implications for Cancer Treatment
The potential impact of this research extends beyond lung cancer patients. "If this works, we could apply it to all other cancers that spread to the brain," Chen said, highlighting the broader therapeutic possibilities.
Immunotherapy has already transformed treatment outcomes for several advanced cancers, including lung cancer. The combination with focused ultrasound technology could open new treatment avenues for patients whose cancers have spread to the brain, offering a non-invasive alternative to surgery and radiation therapy, which often carry higher risks and side effects.
Patients interested in participating in the trial can contact Amanda Hasbrouck at 401-793-9177 for more information about eligibility and enrollment procedures.
