On October 21, 2025 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported the interim results from its ROADS clinical trial (Randomized Controlled Trial of Resection [Surgery] and GammaTile versus Standard of Care) in patients with operable, newly diagnosed brain metastases.1

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The trial, which completed randomization of 230 patients over 30 leading cancer centers in the United States in August 2025, evaluated whether implanting GammaTile – a form of brain tumor radiation that begins immediately at the time of surgery, with no waiting or time lost – could improve outcomes compared with the current standard of care (surgery followed by postoperative external beam stereotactic radiation therapy [SRT]). The standard approach requires a recovery period before radiation can begin, during which remaining microscopic tumor cells may regrow.

The trial was led by Dr. Thomas Beckham, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, and Dr. Jeffrey Weinberg, Professor of Neurosurgery, Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery at The University of Texas MD Anderson Cancer Center. The interim data, presented at the 2025 Congress of Neurological Surgeons by Dr. Weinberg, shows significant and durable improvements in reducing tumor recurrence and increasing surgical bed recurrence-free survival (time to tumor recurrence or death) with GammaTile.

Key Interim Findings

A pre-planned interim analysis was conducted with 168 enrolled patients:1*

GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, and there was a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care [SRT] (hazard ratio 0.42, p=0.0024).
GammaTile showed superiority in overall protection from worrisome radiographic brain changes (either tumor recurrence or radiation-related tissue damage). At the time of analysis, more than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while in the SRT group, more than half of patients had already experienced one of these events by 16 months (hazard ratio of 0.32, p=0.018).
GammaTile demonstrated significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups proving GammaTile delivers superior outcomes without added risk.
"The interim data from the ROADS trial is the first randomized, multicenter evidence showing the superiority of starting radiation immediately at the time of tumor removal with GammaTile for operable brain metastases," says Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies. "These results highlight the importance of immediate, targeted radiation therapy."

"Although the ROADS trial focused on patients with operable brain metastases, the study reflects real-world treatment patterns, where many patients have a large metastasis that needs surgery and small brain metastases that can be well managed with stereotactic radiation without removal," said Weinberg. "In such cases, patients randomized to the GammaTile arm received GammaTile radiation for the operable tumor and stereotactic radiation for the small metastases. These interim results suggest that this approach not only achieves local control but does so with superiority over the existing standard of care. My colleague, Dr. Beckham, and I agree this evidence may redefine how we treat this disease."

The Brain Metastases Challenge

Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life.2 For patients with operable tumors, surgery followed by external beam stereotactic radiation has been the standard of care, yet its limitations are well recognized, with a 1-year tumor recurrence rate of 28%.3 In addition, up to one third of patients miss or delay postoperative radiation due to access barriers, fragmented care pathways, or logistical challenges.4 These treatment gaps leave patients vulnerable to recurrence, decline in brain function, and added burden for families.

GammaTile is designed to overcome these shortcomings by delivering immediate, targeted, and continuous radiation directly into the surgical cavity at the time of tumor removal.5 This ensures that radiation therapy begins when microscopic cancer cells are the most vulnerable—immediately after surgery, at the lowest point of tumor burden—and guarantees that every patient receives radiation treatment. By closing the treatment gap, GammaTile provides more durable tumor control, reduces recurrence risk, and streamlines the care journey for patients.1 Importantly, GammaTile also gives patients and clinicians peace of mind that treatment has started right at tumor removal.

"We are deeply encouraged by these results," said Per Langoe, Chief Executive Officer of GT Medical Technologies. "By providing immediate radiation when and where it is needed most, GammaTile is showing the potential to transform outcomes for patients with operable brain tumors."

(Press release, GT Medical Technologies, OCT 21, 2025, View Source [SID1234656880])