GammaTile May Reduce Risk of Brain Tumor Recurrence or Death

Among patients with operable, newly diagnosed brain metastases, treatment with GammaTile was associated with a greater than 50% reduction in the risk of either tumor recurrence or death compared to standard of care, according to interim results from the ROADS clinical trial.

A news release from GT Medical Technologies, the company behind GammaTile, shared that, at the time of analysis, more than half of patients who received the treatment were free from tumor regrowth as well as radiation-related tissue damage. Additionally, more than half of the patients who received standard of care had experienced one of these events by 16 months.

Rates of treatment-related side effects were reported to remain low and comparable between both groups.

"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 Dr. Michael Garcia, 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 Dr. Jeffrey 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 ROADS trial was led by Dr. Thomas Beckham, an assistant professor in the Department of Radiation Oncology, Division of Radiation Oncology, and Weinberg, a 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 in Houston. Weinberg presented the interim data at the 2025 Congress of Neurological Surgeons.

Design of the ROADS Clinical Trial

The trial has enrolled 230 patients at more than 30 cancer centers across the United States, completing randomization in August 2025 in order to evaluate GammaTile, a type of radiation immediately following surgery, versus the standard of care of surgery followed by external beam stereotactic radiation therapy, an approach requiring a recovery period before the start of radiation. The pre-planned interim analysis was conducted with 168 patients.

What Is GammaTile?

GammaTile, as explained in the news release, is an FDA-cleared bioabsorbable collagen implant embedded with radiation seeds placed into the surgical cavity at the time of tumor removal. It was launched in the United States in March 2020, and has been adopted by more than 100 cancer centers.

"We are deeply encouraged by these results," said Per Langoe, Chief Executive Officer of GT Medical Technologies, in the news release. "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."

Brain Metastases in Patients With Cancer

Up to 40% of patients with cancer are affected by brain metastases, which can have a major impact on survival and quality of life, according to the news release. The current standard of care has a one-year tumor recurrence rate of 28%, and up to a third of patients miss or delay postoperative radiation.

Reference

1. “Breakthrough clinical trial confirms that GammaTile delivers superior tumor control compared to standard of care for patients with newly diagnosed operable brain metastases,” by GT Medical Technologies. News release; Oct. 21, 2025.