Mayfield Neurosurgeon is First in U.S. to Use Targeted GammaTile® Therapy for Patients with Newly Diagnosed Malignant Brain Tumors

CINCINNATI – Vincent DiNapoli, MD, PhD, a neurosurgeon with Mayfield Brain & Spine and Director of the Brain Tumor Center at The Jewish Hospital-Mercy Health, continued to evolve the standard of care this month when he became the first surgeon in the United States to utilize GammaTile® Therapy for the treatment of newly diagnosed malignant brain tumors.

GammaTile Therapy, marketed by GT Medical Technologies, became available to patients in January 2019 and is being used in top cancer treatment centers across the United States. It was initially approved for the treatment of recurrent brain tumors, including glioblastomas, gliomas, meningiomas, and brain metastases. The FDA expanded clearance of the technology in January to include treatment of newly diagnosed malignant brain tumors.

From left, Jake Andreadis of SurgicalOne, Vince DiNapoli, MD, PhD, of Mayfield Brain & Spine, Elizabeth Levick, MD, of OHC, and Larry Langlois of GT Medical Technologies.

GammaTile Therapy, also known as surgically targeted radiation therapy (STaRT), is designed to delay brain tumor recurrence. It consists of a 3D-collagen tile embedded with a cesium radiation source. GammaTile is placed in the tumor cavity at the time of surgery so that it immediately begins to target residual tumor cells with radiation while limiting the impact on healthy brain tissue.

"Our ability to utilize GammaTile for patients who have been newly diagnosed with malignant brain tumors provides a welcome addition to our options for treatment," Dr. DiNapoli said. "I began using the therapy for my patients with recurrent malignancies in August 2019, and I'm encouraged by initial results. I am excited by the FDA's decision to expand the technology to the many patients who can benefit from the treatment during their initial diagnosis."

Elizabeth Levick, MD, a radiation oncologist with OHC (Oncology Hematology Care), said: "Our Brain Tumor Center team is grateful that more of our patients will benefit from this technology. The therapy has the potential to positively impact patient outcomes, treatment compliance, and quality of life."

Dr. DiNapoli and his team are using the therapy in place of implantable radioactive seeds the size of grains of rice.

"Previously, we embedded individual seeds into the brain and glued them in place," Dr. DiNapoli said. "Despite our best efforts, they had the potential to migrate to another part of the brain. With GammaTile, the radiation is embedded into a wafer that is similar to a surgical sponge. This minimizes the worry that individual seeds will migrate from their original placement, and helps protect healthy brain tissue from radiation."

Implanting tiles that contain four seeds rather than placing seeds one by one also cuts down on the length of the surgery and, consequently, the length of time the patient is under anesthesia. "The process is very quick," Dr. DiNapoli said. "It can be done in less than 5 minutes."

Approximately 700,000 Americans are living with some type of brain tumor during a given year. Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with malignant brain tumors have improved very little over the past 30 years. During this time, there have been only four FDA-approved drugs and two FDA-cleared devices available to patients and physicians for the treatment of brain tumors. GammaTile Therapy, which became available to patients with recurrent brain tumors in January 2019, is the most recent treatment cleared or approved by the FDA for the treatment of brain tumors.

GammaTile Therapy is the only radiation therapy specifically designed for use in the brain and offers advantages for patients undergoing surgery for brain tumors. GammaTile begins targeting residual tumor cells immediately at the time of tumor removal surgery while avoiding damage to healthy brain tissue. In addition, the burden of radiation treatment is reduced. Patients receive treatment while going about their daily lives and require no additional trips to the hospital or clinic for radiation therapy.

In a clinical study, GammaTile Therapy gave the average patient approximately ten extra months without a local recurrence with extended overall survival.¹ Clark C. Chen, MD, PhD, head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with GammaTile at the 2019 Society of Neuro-Oncology (SNO) Annual Meeting.

Consistent with data published in a peer-reviewed article, Dr. Chen reported that local control was achieved in approximately 90 percent of patients who underwent gross total resection of their tumor. This impressive result was achieved without an increase in wound complications or length of hospital stay.

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Mayfield Brain & Spine is the full-service patient care provider of the Mayfield Clinic, one of the nation's leading physician organizations for neurosurgical treatment, education, and research. With more than 20 specialists in neurosurgery, interventional neuroradiology, physical medicine and rehabilitation, pain management, and physical therapy, Mayfield Brain & Spine treats 25,000 patients from 30 states in a typical year. Mayfield physicians specialize in the treatment of back and neck pain, sciatica, Parkinson's disease, essential tremor, NPH, epilepsy, brain and spinal tumors, stroke, moyamoya, brain aneurysms, Chiari malformation, scoliosis, kyphosis, facial pain, facial twitch, trauma, concussion, spinal cord injury, and carpal tunnel syndrome. As leading innovators in their field, Mayfield physicians have pioneered surgical procedures and instrumentation that have revolutionized the medical art of neurosurgery for spinal diseases and disorders, brain tumors, and neurovascular diseases and disorders.

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Mercy Health - Cincinnati is part of Bon Secours Mercy Health (BSMHealth.org), one of the top 20 health systems in the United States, one of the largest employers in Ohio and part of the top performing quartile of Catholic health systems for lowest cost per case for patient care.  Mercy Health – Cincinnati makes advanced, compassionate, quality health care easy to help you be well in mind, body and spirit. Mercy Health – Cincinnati has been serving Greater Cincinnati for more than 160 years and provides an integrated network of leading physicians, compassionate caregivers, comprehensive services and exceptional care at more than 180 locations across the region. The Mercy Health – Cincinnati network of care includes five award-winning hospitals, senior living communities, primary care and specialty physician practices, outpatient centers, fitness centers and a variety of outreach programs. Mercy Health Cincinnati hospitals have earned national Truven Health Analytics' 100 Top Hospitals honors more times than all other Cincinnati hospitals combined, placing them among the best hospitals in the nation. Truven has also named Mercy Health Cincinnati as one of the nation's Top 15 health systems five times, more than any other health system in Cincinnati. To learn more visit, mercy.com and engage in the conversation via Mercy Health Cincinnati's social media channels (@mercy_health on Twitter and Mercy Health Cincinnati on Facebook).

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OHC (Oncology Hematology Care) has been fighting cancer on the front lines for more than three decades. We are the region's leading experts in the treatment of nearly every form of adult cancer and complex blood disorder. OHC offers the latest medical, gynecologic and radiation therapy, and is always seeking better treatment options through participation in clinical trials. OHC is the only independent adult cancer practice to offer the ground-breaking CAR-T therapy for adults. OHC is certified by the American Society for Clinical Oncology in the Quality Oncology Practice Initiative Certification Program and is one of only a select few cancer practices nationally to be accepted to participate in the Oncology Care Model, part of The Center for Medicare and Medicaid Innovation Center. At its heart, our approach to cancer care is simple – to surround you with everything you need so you can focus on what matters most: beating cancer. For more information about services and careers at OHC, call 1-888-649-4800 or visit ohcare.com.

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GT Medical Technologies, Inc.

Driven to overcome the limitations of current treatments for brain tumors and raise the standard of care, a team of brain tumor specialists joined forces and formed GT Medical Technologies with a purpose to prevent disease progression and improve quality of life for patients with brain tumors. GammaTile Therapy received FDA 510(k) regulatory clearance for the treatment of all types of recurrent brain tumors in July 2018 and has an established CMS code for Medicare reimbursement. Extensive clinical expertise informed the design of GammaTile Therapy, and deep medical device experience guides the company. The company is headquartered in Tempe, Arizona. For more information, visit https://www.gtmedtech.com/ and follow @GTMedTech on Twitter and on LinkedIn.

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1 Nakaji P, Youssef E, Dardis C, Smith K, Pinnaduwage D, Brachman D. Surgically targeted radiation therapy: a prospective trial in 79 recurrent, previously irradiated intracranial neoplasms. Poster presented at: 2019 AANS Annual Scientific Meeting; April 2019; San Diego, CA.