Phase IV registry data demonstrate 92.3% 12-month local control with low toxicity
TEMPE, Ariz., Feb. 26, 2026 /PRNewswire/ -- GT Medical Technologies, Inc., a company focused on improving the lives of patients with brain tumors, today announced a publication of prospective, multicenter Phase IV data from the ongoing GammaTile® Registry—which has enrolled more than 600 patients to date—evaluating clinical outcomes following surgical resection with immediate, localized GammaTile® radiation therapy in patients with newly diagnosed brain metastases. The study, published in the Journal of Neuro-Oncology, reports local control, leptomeningeal disease (LMD), and safety outcomes at 12 months.
The analysis included 51 patients with 55 newly diagnosed brain metastases treated with surgical resection followed by GammaTile implantation at the time of surgery. With a median follow-up of 12.4 months, the study evaluated local control, LMD incidence, and safety outcomes following immediate radiation delivery to the resection cavity.¹
Key Findings from the Prospective Registry¹
At a median follow-up of 12.4 months, the study reported:
- 92.3% local tumor control at 12 months
- 7.8% cumulative incidence of LMD
- 9.8% overall Grade 3 toxicity, with no cases of radiation necrosis reported
"Delivering radiation at the time of surgery allows us to treat the resection cavity immediately, when residual microscopic disease is the lowest," said Matthew J. Shepard, MD, FCNS, Assistant Professor of Neurosurgery, Drexel University School of Medicine, Allegheny Health Network Neuroscience Institute, and senior author of the study. "These prospective registry data show very high local control and a low incidence of leptomeningeal disease. Importantly, the observed safety profile was consistent with expected routine postoperative management. Together, these findings add to the growing body of evidence supporting surgically integrated radiation approaches."
Local recurrence following surgical resection of brain metastases is a clinical challenge and achieving durable cavity control while preserving surrounding healthy brain tissue is a central treatment objective. In this prospective registry, resection with GammaTile therapy was associated with 92.3% local control at 12 months, demonstrating strong tumor control.¹ The safety profile observed was consistent with expected postoperative management, with a 9.8% rate of Grade 3 toxicity and no reported cases of radiation necrosis.¹ In this registry analysis, the cumulative incidence of LMD was 7.8%.
GammaTile is designed to deliver highly localized radiation directly to the surgical cavity at the time of tumor resection, closing the traditional treatment gap between surgery and radiation therapy. While patients recover from surgery, GammaTile delivers continuous radiation to the area most at risk, targeting microscopic residual tumor cells during a critical period for tumor control. This surgically integrated approach ensures timely, full-dose treatment as part of a patient's initial brain tumor care.
"This publication from the prospective registry adds to important real-world evidence supporting GammaTile as a safe and effective immediate adjuvant radiation therapy in the newly diagnosed brain metastases setting," said Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies.
The authors note that this registry analysis is descriptive in nature and not a randomized comparison. Ongoing and future studies, including randomized trials such as ROADS (NCT04365374), will further clarify the role of GammaTile relative to other radiation strategies in the management of brain metastases.
About GT Medical Technologies, Inc.
GT Medical Technologies was founded by a dedicated team of brain tumor specialists to address unmet needs in brain tumor treatment. The company is committed to improving the lives of patients with brain tumors through innovative solutions that elevate the standard of care.
About GammaTile®
GammaTile is an FDA-cleared, bioabsorbable collagen implant embedded with radiation seeds, designed for patients with operable brain tumors. By delivering radiation directly from within—placed into the surgical cavity at the time of tumor removal—GammaTile provides immediate, localized treatment. This approach targets remaining cancer cells when they are at their lowest levels to help prevent regrowth, while minimizing radiation exposure to healthy brain tissue.
Since its full market launch in the United States in March 2020, GammaTile has been adopted by more than 100 leading centers, underscoring its growing acceptance in both academic and community healthcare settings. For more information, visit gammatile.com and follow @GammaTile on Facebook, Instagram, LinkedIn, and X.
References
- Kite T, Hanft S, Zeller S, et al. Local control and leptomeningeal disease after resection and GammaTile brachytherapy for newly diagnosed brain metastases: results from a prospective study. J Neurooncol. 2026;176(3):199.
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SOURCE GT Medical Technologies
