GT MedTech Marks ROADS Study Milestone

GT Medical Technologies Inc. (GT MedTech) has enrolled the 100th patient in its Radiation One and Done Study (ROADS), designed to compare its U.S. Food and Drug Administration (FDA)-cleared GammaTile with stereotactic radiotherapy (SRT).
 
Patients enrolled in the ROADS clinical trial are randomized into two treatment groups after undergoing a craniotomy with brain metastasis tumor removal: GammaTile implant at the time of surgery versus post-operative SRT. Enrollment in the Phase 3 trial has now surpassed half of the 180 planned patients. They will be followed for up to three years to measure progression-free survival, overall survival, quality of life, neurocognitive status, and physical function.
 
“Large brain metastases needing resection have an unacceptably high recurrence rate, even after post-operative SRT. For some patients it is very difficult logistically to get to daily SRT treatments, which are outpatient and typically occur within three to four weeks after surgery. Delays between surgery and SRT further increases the risk of recurrence. This all underscores the need for a more effective and easier treatment.” GT Medical Technologies Chief Medical Officer Dr. Michael Garcia said. “We are hopeful the ROADS clinical trial can establish an easier treatment option and new standard of care. By starting radiation immediately at time of tumor resection, GammaTile can eliminate the need to wait for outpatient SRT to begin radiation to the resection site, thereby easing the burden on patients and families from multiple outpatient visits and prevent delays to radiation.”
 
GammaTile is a bioabsorbable collagen tile that delivers radiation immediately at the time of surgery, targeting residual cancer cells to help prevent recurrence, while minimizing harm to healthy brain tissue. Each GammaTile has Cesium-131 seeds that deliver a precise dose of radiation focused precisely where it is needed in the tumor cavity to help prevent recurrence.
 
“Brain metastases are the most common tumors that impact the brain, with over 200,000 new patients annually from primary cancers like breast, lung and melanoma. Our dedication to the ROADS trial is fueled by our mission to furnish the highest caliber of clinical evidence through randomized trial research. The ROADS trial will help determine the most efficient and effective treatments after surgical resection,” stated Angela Richardson, M.D., Ph.D., neurosurgical oncologist at Indiana University, which enrolled the100th ROADS study patient.

The study began in 2021 and is expected to be completed in December 2024. 
 
Driven to raise the treatment standard, a team of brain tumor specialists formed GT Medical Technologies. GammaTile is cleared by the FDA to treat patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms. Since its full market release in the United States in March 2020, GammaTile has been offered in more than 100 institutions.