GT Medical Technologies has released interim clinical trial results for its GammaTile radiation implantable in patients with newly diagnosed operable brain metastases.
The ROADS randomized controlled clinical trial compared resection surgery and GammaTile versus the current standard of care (i.e., surgery followed by postoperative external beam stereotactic radiation therapy [SRT]).
The trial included data from 230 patients at more than 30 cancer centers in the U.S. from August 2025. The findings showed that patients who received GammaTile treatment lived longer without tumor regrowth and experienced a greater than 50% reduction in risk of either tumor recurrence or death compared with those who received SRT (hazard ratio, 0.42; p = 0.0024). More than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage in 16 months, while more than half of patients who had received SRT had already experienced one of these events.
Furthermore, there was no increase in safety concerns, with comparable rates of treatment-related side effects.
GammaTile was cleared by the U.S. Food and Drug Administration in 2018 for recurrent brain tumors and in 2020 for newly diagnosed brain tumors. Its full market launch in the U.S. was in March 2020.
