New Clinical Trial Evaluates GammaTile Therapy for Metastatic Brain Tumors

GT Medical Technologies, Inc. recently announced the first patient has been enrolled in a multicenter, randomized controlled trial. The trial aims to compare outcomes of patients with newly diagnosed, large metastatic brain tumors who receive the standard of care treatment, resection surgery and Stereotactic Radiotherapy (SRT), to those treated with resection surgery and GammaTile Therapy.

“Enrolling the first patient in this significant trial by such a well-respected group of brain tumor centers is a pivotal milestone for GammaTile Therapy, as we continue to see increased usage across the country for this FDA-cleared breakthrough treatment,” said Matt Likens, President and CEO of GT Medical Technologies. “Previous trials that provided a robust set of evidence leading to FDA clearance have demonstrated very favorable clinical outcomes, but this is the first to compare surgery plus GammaTile therapy against the standard of care in patients with newly diagnosed metastatic brain tumors, and we look forward to the results.”

Unlike SRT, which targets tumors using focused radiation beams delivered from outside of the body in repeat in-person clinical visits, GammaTile delivers an immediate, therapeutic radiation dose from the tiles placed inside the brain at the tumor site immediately after tumor removal. GammaTile is designed to protect healthy tissue and minimizes radiation side effects, including hair loss. Over time, the collagen tiles are naturally absorbed into the surrounding tissue, eliminating the need for surgery to remove them.

The study is enrolling 180 patients with large metastatic brain tumors of any pathology. The most common primary sources of metastatic brain tumors are lung, breast, renal, GI, and skin cancers. The largest lesion (>2.5-5 cm) will be treated with either surgery with GammaTile Therapy or surgery followed by SRT. Up to three additional unresected lesions may be treated with SRT alone. The randomization of the two trial arms will also be stratified by age, histology, number of brain metastases, size of the index lesion, the use of immunotherapy, and more. The trial will measure local tumor control, overall survival, functional status, neurocognition, and quality of life out to 24-months following treatment, with data collected at 1, 3, 6, 9, 12, 16, and 24-months.¹

The trial is led by The University of Texas MD Anderson Cancer Center, joined by other top brain tumor centers across the U.S. The trial will be co-directed by Jeffrey Weinberg, M.D., professor, deputy chair and vice-chair of clinical operations for Neurosurgery at MD Anderson, and Thomas Beckham, M.D., Ph.D., professor of Radiation Oncology at MD Anderson.

“GT Medical Technologies was founded by a group of brain tumor specialists committed to a scientific, evidence-based approach, so having such a well-respected group of brain tumor centers participate in this study is very rewarding,” said Dr. Lisa Misell, Vice President of Clinical Affairs, GT Medical Technologies. “It's critical to elevate the standard of care and find a viable treatment option for patients diagnosed with large metastatic brain tumors.”

¹ https://clinicaltrials.gov/ct2/show/NCT04365374