GESTALT CLINICAL TRIAL for PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMAS (GBMs)  | ENROLLING NOW

Treatment Overview

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GammaTile

GammaTile® is an implanted surgically Targeted Radiation Therapy also known as STaRT.1,2

GammaTile Therapy (STaRT)

  • Internal radiation implant
  • Targeted to the tumor site
  • Treatment begins immediately at completion of brain tumor removal surgery

About the size of a postage stamp, the bioresorbable GammaTile collagen tile contains 4 radiation seeds. Placed by the neurosurgeon at the completion of brain tumor removal surgery, the GammaTiles immediately begin delivering targeted radiation to the area where the tumor was removed, limiting radiation exposure to healthy tissue.

Over time, and after the therapeutic dose of radiation has been delivered, the body naturally absorbs the collagen GammaTiles. No follow-up surgery for removal is needed.

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The Stupp protocol

Named after its founder, the Stupp protocol consists of external beam radiation therapy (EBRT) and oral chemotherapy with Temodar®, also called temozolomide, or TMZ.3

Stupp protocol3

  • 4 weeks of EBRT, 5 days per week 
  • Combined with 4 weeks of daily oral chemotherapy (TMZ)
  • Followed by a 4-week break from treatment (no radiation or chemotherapy)
  • Then 6 more months of TMZ only (5 days per month)

Radiation and chemotherapy are combined to optimize treatment results.3

References:

  1. Brachman D, Youssef E, Dardis C, Smith K, Pinnaduwage D, Nakaji P. Surgically targeted radiation therapy: safety profile of collagen tile brachytherapy in 79 recurrent, previously irradiated intracranial neoplasms on a prospective clinical trial. Brachytherapy. 2019;18(3):S35-S36. 
  2. GammaTile Therapy Instructions for use. GT Medical Technologies; 2020.
  3. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996.

The GESTALT Trial is sponsored by GT Medical Technologies, Inc., the makers of GammaTile®. Please discuss the risks and benefits of participating in this clinical trial with your care team.

Indication: GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and recurrent intracranial neoplasms.

Safety Information: The potential for, and symptoms of, adverse events related to radiation exposure vary depending on the radiosensitivity of the exposed tissue, the amount of radiation delivered, and the placement of GammaTile(s). GammaTile should not be used for patients with a known history of hypersensitivity to bovine-derived materials.

GESTALT CLINICAL TRIAL for PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMAS (GBMs)

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©2022 GT Medical Technologies, Inc. I All rights reserved I GammaTile is a registered trademark of GT Medical Technologies, Inc.