GammaTile® Marks Milestone: 100th Patient Enrolled in Groundbreaking ROADS Phase 3 Clinical Trial for Newly Diagnosed Metastatic Brain Tumors

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Apr 09, 2024, 07:30 ET

Randomized Controlled Trial Targets Residual Cancer Cells during Brain Surgery with Implant Delivering Radiation, Aiming to Advance Local Control

TEMPE, Ariz., April 9, 2024 /PRNewswire/ -- GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has enrolled the 100th patient in its ROADS clinical study. ROADS, or Radiation One and Done Study, is the randomized control trial (RCT) designed to compare FDA-cleared GammaTile with stereotactic radiotherapy (SRT).

GT Medical Technologies CMO Michael Garcia, MD

Patients enrolled in the ROADS clinical trial are randomized into two treatment groups following 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 3-4 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." emphasized Dr. Michael Garcia, Chief Medical Officer at GT Medical Technologies. "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 right 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" Angela Richardson, MD, PhD, Neurosurgical Oncologist at Indiana University where the100th patient in the ROADS trial was enrolled. The study began in 2021. Completion is targeted for December 2024.

For more information on the study, visit www.roadsstudy.com.

About GT Medical Technologies, Inc.

Driven to raise the standard of care and improve the lives of patients with brain tumors, a team of brain tumor specialists formed GT Medical Technologies. GammaTile is FDA-cleared as a treatment for 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 over 100 leading institutions, with more centers being added each month. For more information, visit www.gtmedtech.com and follow @GammaTile on Twitter and LinkedIn.

Media Contacts:

Lori Kagan
GT Medical Technologies
[email protected]

Dawn Fallon
New Dawn Communications
[email protected]

Reference:

Currently, twenty-three institutions across the U.S. are participating in the ROADS clinical trial, which includes the following sites: