December 11, 2019 – The University of Virginia has opened a clinical trial to assess the safety of using focused ultrasound to treat advanced solid tumors. Researchers will investigate patients’ immune response in tumor tissue following focused ultrasound ablation. Focused ultrasound may be administered alone or in combination with a cancer immunotherapy drug (PD-1 antibody blockade), which itself has been proven effective in treating various forms of skin, lung, renal, and other cancers, and topical imiquimod, which can be used to enhance immune-mediated responses to tumors in the skin.
Clinical data currently support the benefit of focused ultrasound ablation of certain cancerous tumors. These effects may be mediated in part by the enhancement of anti-tumor immune responses. “We believe that when used in combination with checkpoint inhibitors, focused ultrasound will optimize the body’s immune response to solid tumors,” said study sponsor Craig L. Slingluff, Jr., MD, Professor of Surgery at UVA Health and Director of the UVA Cancer Center Human Immune Therapy Center. “Because focused ultrasound is noninvasive and has low toxicity, we will be able to recruit patients from a wide health range.”
Though PD-1 antibody blockades have proven successful in treating a range of solid cancer tumors, they still fail in about 70–80% of patients. This study will provide an opportunity to investigate whether the addition of focused ultrasound ablation will improve patients’ immune response. The focused ultrasound ablation will be delivered using the Echopulse device, which is manufactured by Theraclion.
“We are hopeful that the changes in the immune environment induced by focused ultrasound at the tumor site may bolster the systemic immune response, resulting in not only an effect at the tumor but also treatment benefit at distant sites,” said principal investigator Lynn Dengel, MD, a surgical oncologist at UVA Health.
The Focused Ultrasound Foundation is providing funding to support Dr. Slingluff’s and Dr. Dengel’s study. Chairman of the Foundation, Neal F. Kassell, MD, said, “Of the many possible applications of focused ultrasound technology, using it for cancer immunotherapy may be the one with the potential to impact the most lives. We hope that focused ultrasound will prove to be part of a more effective, durable approach to fighting cancer.”
Patients interested in learning more about trial eligibility should visit ClinicalTrials.gov. The ClinicalTrials.gov Identifier is NCT04116320.
About Focused Ultrasound
Focused ultrasound uses ultrasound energy guided by real-time imaging to treat tissue deep in the body without incisions or radiation. Focused ultrasound is FDA approved in the United States to treat essential tremor, Parkinson’s, uterine fibroids, pain from bone metastases, and the prostate. The technology is in various stages of research and development for more than 130 diseases.
About UVA Health
UVA Health includes a 612-bed hospital, the UVA School of Medicine, a level I trauma center, nationally recognized cancer and heart centers, and primary and specialty clinics throughout Central Virginia. UVA is recognized for excellence by U.S. News & World Report, Best Doctors in America, and America's Top Doctors.
About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of this noninvasive technology. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration, and building awareness among patients and professionals. Since its establishment in 2006, the Foundation has become the largest nongovernmental source of funding for focused ultrasound research. www.fusfoundation.org
[High-resolution images available upon request.]