Vidant Health and GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, announced the first patient has been enrolled into its registry trial of GammaTile®, a FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) for newly diagnosed malignant and recurrent brain tumors. The study will evaluate the safety and effectiveness of GammaTile Therapy in a real-world setting in up to 50 brain tumor centers across the United States.
“GammaTile Therapy was created with the goal of elevating the standard of care, and this registry will help demonstrate how it is making a measurable impact on patients diagnosed with brain tumors,” said Matt Likens, President and CEO of GT Medical Technologies. “We have been encouraged by previous studies showing that GammaTile Therapy delays recurrence and may extend survival, which led to FDA clearance. This registry will shed further light on the real-world benefits of STaRT for people with brain tumors.”
The multicenter observational study will enroll 600 patients with brain tumors of any pathology who have received treatment with GammaTile Therapy. Data will be collected before and after surgery and implantation of GammaTiles and at 1, 3, 6, 9, 12, 18 and 24 months, then every 6 months through 5 years. Primary and secondary endpoints will include local tumor control, overall survival, quality of life, physical function, and safety. This will be the first observational registry study of resection plus GammaTile. Data from the study will be used to benchmark clinical outcomes for GammaTile Therapy and allow for comparisons to existing standard-of-care treatments for patients with brain tumors.
Over 700,000 Americans are living with a brain tumor today. Despite the efforts of the most skilled brain tumor specialists in the world, outcomes for patients with brain tumors have improved little over the past 30 years. GammaTile is the latest FDA-cleared treatment for newly diagnosed malignant and recurrent brain tumors, and recently announced data show promising clinical outcomes for patients diagnosed with high grade gliomas, brain metastases, and aggressive meningiomas.
“As a neurosurgeon, I am always looking for treatments that help give my patients more time and a better quality of life, and from what I have seen in my patients to date, GammaTile Therapy offers both,” said Dr. Stuart Lee, Chief of Neurosurgery at Vidant Medical Center in Greenville, North Carolina. “It is an honor to have treated and enrolled the first patient in this registry. My hope is that the insights gleaned from this study will give us information to continue improving the standard of care for patients with brain tumors.”
In addition to the registry trial, two additional studies evaluating GammaTile Therapy in patients with brain metastases were announced at the 2020 Society of Neuro-Oncology Virtual Meeting on Brain Metastases in August. Those studies, which are led by The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, are expected to begin enrollment in Q4 2020.