HCA Healthcare Research Institute hosts new clinical trial using noninvasive focused ultrasound in combination with systemic immunotherapy to treat brain metastases

HCA Healthcare’s Johnston-Willis Hospital in Richmond, Virginia, is the first hospital in the United States to provide treatment in a new clinical trial for patients with brain metastases from lung cancer. This clinical trial, conducted by HCA Healthcare Research Institute and sponsored by Insightec, a global healthcare company pioneering the use of focused ultrasound technology, investigates the benefit of combining noninvasive focused ultrasound with systemic immunotherapy as an alternative.

Johnston-Willis Hospital is hosting the trial and has already enrolled the first two U.S. patients who are currently undergoing a total of six treatment cycles each. The patients have metastatic brain cancer, which originated from cancer cells spreading to the brain from the primary tumor in their lungs. The new treatment uses Insightec’s system to open the blood-brain barrier (BBB), which defends the brain against harmful substances, but also prevents critical medications from being delivered. By opening the BBB, non-small cell lung cancer medications may reach and target the critical lesions in the brain.

"The potential success of this trial could be groundbreaking in the management of metastatic brain tumors, not only for lung cancer, but also for breast cancer and melanoma," said neurosurgeon K. Singh Sahni, the principal investigator of the trial and medical director of the Neuroscience and Gamma Knife Center at Johnston-Willis Hospital. “There are remarkable new cancer medications that have excellent results in the body, yet cannot reach the brain because the blood-brain barrier currently impedes their flow. By opening the BBB, the hope is that such therapies will lead to equally good therapeutic responses in the brain as it currently has on other organs, such as the lung and liver.”

The MR-guided focused ultrasound system was developed by Insightec and is already FDA-approved to use thermal ablation to treat essential tremor and Parkinson’s Disease that do not respond well to medication treatment. Johnston-Willis Hospital has treated 150 people living with essential tremor using focused ultrasound. In this trial, a different Insightec system that was developed solely to temporarily open the BBB and allow passage of immunotherapy to enable noninvasive treatment of brain tumors, is used.

“It is incredibly important for both patients, and the healthcare industry as a whole, to participate in potentially groundbreaking clinical trials like this,” said Dr. Michael Cuffe, executive vice president and chief clinical officer of HCA Healthcare. “It is a privilege to utilize the scale of HCA Healthcare to explore new treatment options to help deliver better care to patients.”

HCA Healthcare Research Institute is the multispecialty clinical research arm of HCA Healthcare focused on collaborating with industry partners to advance care. Currently, the HCA Healthcare Research Institute has 36 research sites, focusing on interventional, non-therapeutic, and records-based research. As of September 30, 2023, the institute has participated in more than 350 trials across the country. HCA Healthcare is the single largest health system research site network with more than 37 million patient encounters annually. The HCA Healthcare Research Institute offers a site network with national scientific leaders and community-based hospitals across the country in virtually every therapeutic area.

“These treatments mark another exciting milestone in the forward trajectory of focused ultrasound treatment,” said Dr. Maurice Ferre, CEO and chairman of the board of Insightec. “Insightec continues to lead the way on utilizing focused ultrasound for innovative treatments to a variety of diseases and conditions. We are proud to be providing care and relief for more and more people every day.”

The trial is expected to last through August 2024. Johnson-Willis Hospital was the first in the United States to receive The Joint Commission’s Gold Seal of Approval for brain tumor care.

About HCA Healthcare

Nashville-based HCA Healthcare is one of the nation’s leading providers of healthcare services comprising 182 hospitals and approximately 2,300 ambulatory sites of care, including surgery centers, freestanding ERs, urgent care centers, and physician clinics, in 20 states and the United Kingdom. With its founding in 1968, HCA Healthcare created a new model for hospital care in the United States, using combined resources to strengthen hospitals, deliver patient-focused care and improve the practice of medicine. HCA Healthcare has conducted a number of clinical studies, including one that demonstrated that full-term delivery is healthier than early elective delivery of babies and another that identified a clinical protocol that can reduce bloodstream infections in ICU patients by 44%. HCA Healthcare is a learning health system that uses its more than 37 million annual patient encounters to advance science, improve patient care and save lives.

About Insightec

Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in München, Dallas, Shanghai, and Tokyo.

All references to “Company,” “HCA” and “HCA Healthcare” as used throughout this document refer to HCA Healthcare, Inc. and its affiliates.

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