GT Medical Technologies Announces First Patient Enrolled in Clinical Trial Evaluating GammaTile® Therapy in Patients With Metastatic Brain Tumors


TEMPE, Arizona., May 11, 2021 / PRNewswire / – GT Medical Technologies, Inc. announced today that the first patient has been enrolled in a multicenter randomized controlled trial. The trial aims to compare the outcomes of patients with newly diagnosed large metastatic brain tumors who receive standard treatment, resection surgery and stereotaxic radiation therapy (SRT), with those treated with resection surgery and GammaTile® Therapy.

“Enrolling the first patient in this important trial by such a respected group of brain tumor centers is a critical milestone for GammaTile therapy as we continue to see increased use across the country for this revolutionary FDA-approved treatment. “, said Matt likes, President and CEO of GT Medical Technologies. “Previous trials that provided a strong body of evidence leading to FDA clearance showed very favorable clinical results, but this is the first to compare surgery associated with GammaTile treatment to standard of care in patients with newly diagnosed metastatic brain tumors, and we look forward to the results. “

Unlike SRT, which targets tumors using focused beams of radiation delivered from outside the body during repeated in-person clinical visits, GammaTile delivers an immediate therapeutic dose of radiation from the tiles placed inside. brain to the tumor site immediately after tumor removal. GammaTile is designed to protect healthy tissue and minimize the side effects of radiation, including hair loss. Over time, the collagen tiles are naturally absorbed into the surrounding tissue, eliminating the need for surgery to remove them.

The study is recruiting 180 patients with large metastatic brain tumors of any pathology. The most common primary sources of metastatic brain tumors are cancers of the lung, breast, kidney, digestive tract and skin. The larger lesion (> 2.5 to 5 cm) will be treated either by surgery with GammaTile Therapy or by surgery followed by SRT. Up to three additional unresected lesions can be treated with SRT alone. The randomization of the two trial arms will also be stratified by age, histology, number of brain metastases, size of the index lesion, use of immunotherapy, etc. The trial will measure local tumor control, overall survival, functional status, neurocognition and quality of life for up to 24 months after treatment, with data collected at 1, 3, 6, 9, 12 , 16 and 24 months.1

The trial is led by the University of Texas MD Anderson Cancer Center, joined by other major brain tumor centers across the U.S. The trial will be co-led by Jeffrey Weinberg, MD, professor, vice president and vice president of clinical operations for neurosurgery at MD Anderson, and Thomas beckham, MD, Ph.D., professor of radiation oncology at MD Anderson.

“GT Medical Technologies was founded by a group of brain tumor specialists committed to a scientific and evidence-based approach, so it is very gratifying to have such a respected group of brain tumor centers in this study,” said the doctor. Lisa Misell, Vice President of Clinical Affairs, GT Medical Technologies. “It is essential to raise the standard of care and find a viable treatment option for patients diagnosed with large metastatic brain tumors.”

About GT Medical Technologies, Inc.
In an effort to overcome the limitations of current brain tumor treatments and raise the standard of care, a team of brain tumor specialists have joined forces and trained GT Medical Technologies to improve the lives of brain tumor patients. . Its GammaTile therapy has received regulatory clearance from the FDA 510 (k) for the treatment of all types of recurrent brain tumors and newly diagnosed malignancies. Patients receive their radiation therapy course while going about their daily business, requiring no additional travel to the hospital or clinic for radiation therapy. GammaTile is available in the best brain tumor centers United States. For more information or to find a GammaTile center near you, visit https://www.gtmedtech.com/ and follow @GTMedTech on Twitter and LinkedIn.

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1 https://clinicaltrials.gov/ct2/show/NCT04365374

SOURCE GT medical technologies




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