On October 11, 2022 GT Medical Technologies, Inc. reported the enrollment of the first patient into the GESTALT (GammaTile Enhanced Stupp ALTernative Trial) of GammaTile Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed glioblastomas (Press release, GT Medical Technologies, OCT 11, 2022, View Source [SID1234621888]).
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The GESTALT Clinical Trial will include immediate radiation with GammaTile Therapy followed by the Stupp protocol.
Glioblastoma (GBM) is the most common primary malignant brain tumor in adults, yet effective treatment remains a challenge. In 2005, the Stupp protocol became the standard of care—tumor resection, followed by adjuvant temozolomide (TMZ) and external beam radiation therapy (EBRT) several weeks post-surgery. Unfortunately, patient outcomes remain poor, and there have been few advancements over the last decades.
GammaTile Therapy is the only GBM treatment to be FDA cleared in the past decade and one of only 7 FDA-cleared or -approved GBM treatments in the past 50 years. In clinical trials and patient case studies, GammaTile Therapy provides immediate radiation therapy at the time of surgical resection giving patients an effective treatment alternative for newly diagnosed malignant and recurrent brain tumors of all types.
GammaTiles are radiation implants specifically designed for use in the brain. Each resorbable collagen GammaTile is embedded with Cs-131 radiation sources. The neurosurgeon implants GammaTiles in the cavity created by tumor removal. They begin working immediately to combat residual tumor cells.
The GESTALT Clinical Trial will include immediate radiation with GammaTile Therapy followed by the Stupp protocol. The total radiation administered in this clinical trial with GammaTile Therapy and EBRT will be within standard radiation treatment levels.
"Our goal is to demonstrate how starting radiation immediately at the completion of resection and combining it with the Stupp protocol can improve outcomes," said Matt Likens, president and CEO of GT Medical Technologies. "Since GBM is highly proliferative, approximately 50% of patients experience rapid early progression before they can start the Stupp protocol treatment."
"This is an important study built on sound clinical data with the potential to reshape how we approach glioblastoma treatments in the future. We are pleased to offer this study to our patients at M Health Fairview," commented Dr. Clark Chen, the Lyle French Chair and Head of the Department of Neurosurgery, University of Minnesota Medical School. Dr. Chen played an instrumental role in designing the GESTALT Clinical Trial and leads the GESTALT Clinical Team at this site.