Rhode Island Hospital recently launched the nation’s first clinical trial looking into the use of non-invasive focused ultrasound in combination with immunotherapy to treat brain metastases, the hospital announced.
This study will assess the safety and efficiency of focused ultrasound technology as a possible alternative to usual treatments like surgery and radiation therapy, which can be risky and have a lot of side effects.
Dr. Clark Chen, professor of neurosurgery and director of the Brain Tumor Program at Brown University Health, answered Providence Business News' questions about the trial.
PBN: How did Brown Health come to be the first to launch this study and where will it be conducted?
CHEN: Brown University Health became the first to launch the LIMITLESS clinical trial through a combination of visionary leadership, a culture of tireless dedication to our patients, and an unwavering commitment to clinical innovation—made possible by a transformative philanthropic gift from the Rainwater Foundation. This groundbreaking initiative reflects the mission and impact of Rhode Island Hospital, where the study will be conducted, and underscores our deep commitment to advancing neuroscience, improving patient outcomes, and shaping the future of care for all Rhode Islanders and beyond.
PBN: What stage is the study currently in? What does that involve?
CHEN: The LIMITLESS study is testing a promising new approach for treating lung cancer that has spread to the brain, known as brain metastasis. Researchers are exploring whether focused ultrasound—a technique that uses sound waves to temporarily open the blood-brain barrier (BBB)—can help immunotherapy drugs reach tumors more effectively. The BBB is a natural protective layer of tightly packed cells that shields the brain from harmful substances, but it also makes it difficult for many cancer treatments to reach brain tumors. By briefly and safely opening this barrier, focused ultrasound may allow life-saving drugs to better target cancer cells and strengthen the body’s ability to fight disease.
Phase 1 results of the study demonstrated both the safety and early promise of this treatment approach. The study is currently in Phase 2 which means participants will be randomly assigned to receive either standard immunotherapy alone or immunotherapy combined with focused ultrasound. Comparing the two groups will help researchers determine whether the combined approach offers a meaningful advantage for patients.
PBN: Who can qualify for this trial?
CHEN: To qualify for the LIMITLESS study, participants must meet certain medical criteria. In general, the study is open to adults diagnosed with non-small cell lung cancer that has spread to the brain. Participants must also be eligible to receive immunotherapy, a treatment that helps the immune system target and destroy cancer cells and be in good overall health to safely undergo both focused ultrasound and immunotherapy.
Some conditions may prevent individuals from participating, for example, those with other serious medical issues, a history of certain brain surgeries or radiation treatments, or individuals who are pregnant or breastfeeding. Participants must also be able to have MRI scans, which help researchers monitor treatment progress, and be able to understand the study and provide informed consent.
PBN: What kind of result would indicate that this could be a viable cancer treatment?
CHEN: Phase 2 of the LIMITLESS study is designed to see whether combining focused ultrasound with immunotherapy is more effective than immunotherapy alone at shrinking tumors or slowing their growth. If the results show a clear benefit, it will mark an important step toward making this combination a new standard of care for patients with non-small cell lung cancer that has spread to the brain.
PBN: What kinds of cancer could be treated with this method?
CHEN: While the LIMITLESS study is focused on treating non-small cell lung cancer that has spread to the brain, its success could have far-reaching implications. If this approach proves effective, it could pave the way for treating other types of brain metastases, such as those that originate from breast or kidney cancers, in a similar way. It may also open new possibilities for pairing focused ultrasound with other cancer therapies beyond immunotherapy. This research could lay the foundation for a new generation of treatments aimed at improving outcomes for patients with many forms of brain metastasis.
Katie Castellani is a PBN staff writer. You may contact her at Castellani@PBN.com.
