On February 13, 2023, the first patient in the USA was treated in the MUSE breast cancer ablation system, a technology made at the University of Utah that has the ability to kill breast tumors without surgery. It marks a turning point in the evolution of less invasive methods for treating breast cancer.
The MUSE system was developed by Allison Payne, PhD, a faculty member in the Department of Radiology and Imaging Sciences and a part of the Utah Center for Advanced Imaging Research (UCAIR). Payne and her team, including fellow faculty members Dennis Parker, PhD, Rock Hadley, PhD, Henrik Odéen, PhD, and engineers Robb Merrill and Emilee Minalga developed their first prototype in 2012 and tested it on goats. A decade later, they have finally passed all of the hurdles to receive FDA investigational device exemption and IRB approval to conduct clinical trials in human subjects.
“The amount of people it took to make this successful is just amazing,” says Payne. “I am thrilled that it went so well,” she adds.
How the MUSE System Works
The MUSE system combines two noninvasive technologies: MRI scanning and high-intensity focused ultrasound. Payne’s device is based around a special table she developed to help a woman feel comfortable for a long time in the MRI machine. A hole in the table allows a breast to be suspended in water, which provides an ideal medium for the ultrasound waves to travel into the body. The ultrasound is generated by a transducer the shape of a visor in ski goggles, containing 256 little vibrating elements that concentrate the waves into a point the size of a grain of rice.
The ultrasound transducer is able to be positioned to deliver its energy precisely into the tumor. All of this happens while the MRI machine scans the patient, allowing the team to see in real time exactly where the device is delivering its energy. Once they are in the exact spot, they deliver 30-second-long “sonications,” which heat up the cancerous tissue in that small point until it is dead. The full procedure involves a number of sonications that cover the entire three-dimensional space of the tumor.
“Our focused ultrasound lab is truly a global leader and innovator in developing and improving this clinical tool,” says Satoshi Minoshima, MD, PhD, the Anne G. Osborn Chair of Radiology and Imaging Sciences. “Drs. Payne, Parker, and their teams are internationally respected scientists who enrich the entire University of Utah research community,” he adds.
The First Patient
Payne, Odéen, and research associate Sara Johnson arrived at the Clinical Neurosciences Center at 6:00 am to run quality assurance on all of the equipment and software. Nicole Winkler, MD, a breast imaging faculty member of the Department of Radiology and Imaging Sciences, arrived a half an hour before the procedure was scheduled to begin. Winkler was the physician directing the treatment. During the procedure, Odéen manned the MR machine, Johnson ran the ultrasound software, and Payne hovered throughout the MRI suite, double-checking everything.
The patient was not far behind Winkler, having stayed overnight after a 3-hour drive from Idaho and arriving early for her appointment. She was in a good mood, too, even though this was her third MRI appointment; the first two made sure she was a good candidate for the procedure and helped the team plan for precise placement of the device. She changed into a hospital gown and took some pre-procedure medications like Tylenol for pain, but no sedation.
The team also included MRI technologists, Derek Maxfield and Ryan Hardman, and study nurse, Jan Wall. Everyone fell into their work, taking time to place the device correctly, check on the patient’s comfort, and then accomplish some sonications.
“It was another example of when you have a great team, things can go really well,” Payne says. “Our team has grown in skill and ability over our years of testing.”
The total time of the procedure was 90 minutes, and the patient stood up at the end as happy as she was when she started. “She felt some heat and discomfort towards the end of the sonications as the tissue heated up,” Payne relates, “but she was a real trooper and went through it all very well."
The Clinical Trial
Payne is on year six of an NIH R37 Merit Award from the National Cancer Institute, a distinction described by the NIH as providing “long-term grant support to investigators whose research competence and productivity are distinctly superior and who are highly likely to continue to perform in an outstanding manner.” Their clinical trial is targeting up to 34 patients, and they are hoping to perform the procedure on two women a month.
Cindy Matsen, MD, a faculty member in the Department of Surgery, breast surgeon at the Huntsman Cancer Institute (HCI), and a long-time collaborator of Payne, is the principal investigator for the clinical trial. Matsen has led the effort to assemble the clinical team, including Dr. Evin Gulbahce, Dr. Christos Vaklavas and Dr. Jeffrey Horn. The HCI Clinical Trials Office is managing the MUSE system trial, recruiting patients and helping with their complex scheduling, scanning, and procedural visits. Nicole Cottam and Lisa Pinkney in the Department of Radiology and Imaging Sciences have been integral in scheduling patients for the multiple MRI exams needed for the procedure.
“The HCI Clinical Trials Office and Department of Radiology and Imaging Sciences staff have been amazing,” states Payne, “I am very thankful for their work.
The clinical trial is a treat and resect study, not meant to replace the single tumor lumpectomy that each patient will receive. The team will ablate up to 50% of the tumor, then the HCI surgeons will remove the whole tumor.
“The clinical trial in no way impedes the patient’s standard of care. Patients that participate are generously giving their time so that we can evaluate this technology for future use,” explains Payne.
Once the tumor has been removed, the study pathologist Dr. Evin Gulbahce will evaluate the tumor and the ablation that was done. The team will compare the pathology report to their MR images to evaluate how their MR planning and treatment monitoring agrees with the pathology results.
Women who are interested in helping to usher in a new era of noninvasive breast cancer treatments can ask their doctor about participating in the study. More information can be found on the ClinicalTrials.gov webpage for this study.
What the Future Holds
Payne is thrilled to be in the phase of the project where over a decade of work is finally being used for patient care. She anticipates that the study will show that the MUSE system is as precise as promised and that the MR treatment monitoring allows for a safe and tolerable procedure. As for when it will be commercially available for women to choose as a treatment, Payne hopes that this will be 5 years from now.
In the meantime, the UCAIR team continues to innovate and improve on medical imaging. The custom MRI coils used in this study and built by Rock Hadley, for instance, impressed Winkler. “The images made by the MUSE system are incredible and of diagnostic quality,” she states. Hadley makes custom MRI coils for many scenarios like carotid artery imaging in the neck and spine imaging studies.
More information on the work being done at UCAIR can be found on their website.