SURGICALLY TARGETED RADIATION THERAPY FOR PATIENTS WITH OPERABLE BRAIN TUMORS

Right Treatment. Right Time. Right Place.

GammaTile Therapy is a Surgically Targeted Radiation Therapy 

(STaRT) that provides immediate, dose-intense treatment at the completion of resection. By getting a head STaRT on fighting the tumor, resection plus GammaTile Therapy can extend local

recurrence-free survival with minimal complications, reduced patient burden, and assured compliance.[1]

 

Elevating Outcomes With Optimized Dosimetry

GammaTile Therapy vs Intensity-Modulated Radiation Therapy (IMRT)

GammaTile is designed with uniform radiation-source spacing to ensure an even dose distribution. The favorable depth-dose profile optimizes local tumor control.[2]

The colors indicate the radiation location and intensity from the 2 types of treatment. Blue-green indicates lower radiation levels. Red indicates higher levels. The extracranial dose is likely lower than shown, as the planning system did not utilize inhomogeneity corrections.

Proven Efficacy

Improved Local Tumor Control

For patients with recurrent meningiomas and recurrent brain metastases, the use of GammaTile Therapy demonstrated a significant delay in treatment site recurrence compared to their previous treatments.[3,4]

MENINGIOMA PATIENTS RECURRENCE FREE AT 2 YEARS[3]

BRAIN METASTASES PATIENTS RECURRENCE FREE AT 1 YEAR[4]

Overall Survival in Patients With Recurrent GBM

GammaTile Therapy demonstrates a potential for improved overall survival when comparing the effectiveness of surgery plus GammaTile Therapy to other treatment modalities across different clinical studies in patients with recurrent glioblastoma (GBM).[5,6]

RECURRENT GBM PATIENTS MEDIAN OVERALL SURVIVAL[5,6]

Advancing Safety

Designed with the brain’s delicate environment in mind to limit radiation changes in healthy tissue[7]

* Defined as common terminology criteria for adverse events (CTCAE), Grade 3–5 possibly or probably related to GammaTile Therapy placement occurring at any time during follow-up.

 
 

How It Works. An Eloquent Solution.

GammaTile Therapy targets tumor cells while preserving brain tissue. Surgically guided treatment of the local radiation dose to the operative bed optimizes the therapeutic margin while minimizing complications.[1]

 

Structural offset of the radiation source from the brain tissue prevents harmful direct seed-to-tissue contact and enables intraoperative adjustment. 

Enhanced local control and proven efficacy[2,11]

  • 50% of the therapeutic dose is delivered within the first 10 days after surgery, which helps prevent residual tumor cells from replicating.[11]

  • 88% of the therapeutic dose is delivered within 30 days, with more than 95% of the dose delivered by 6 weeks.[11]

  • A favorable depth-dose profile optimizes local tumor control.[2]

Cesium-131 Distribution and Intensity
Bioresorbable, conformable collagen tile preserves healthy tissue 
  • Provides a structural offset of the radiation source from normal brain tissue[11]

  • Enforces uniform radiation-source spacing, both within a single tile and between multiple tiles[11]

  • Minimizes local hot and cold spots[11]

  • Facilitates rapid, accurate placement to deliver a predictable radiation dose[11]

Uniform Radiation Source,

Structurally Offset Design

2-cm height  |  2-cm width  |  4-mm thickness

What I like about GammaTile is that they’re taking a radiation technology that already exists and making it safer and easier to deliver… [It] should be equally effective and faster to implant after tumor surgery…[It’s] better for patients (with less anesthesia time) and safer for the staff (with less exposure in the OR).

  Dr Helen Shih  

Radiation Oncologist at Massachusetts General Hospital

 

GammaTile Therapy Webinars

Clinical presentation  “GammaTile Therapy: Why The Next Big Thing In Brain Tumor Treatment Is Something Small”.
In this webinar, Dr David Brachman and Dr Mehee Choir review clinical data from the prospective GammaTile clinical trial, along with recent clinical publications and trial plans, and examine brain tumor patients’ access to radiation therapy.
Watch here

The clinical presentation “A Neurosurgeon’s Perspective On GammaTile Therapy For Recurrent Meningiomas” is led by

Dr Zabramski. This webinar reviews the meningioma subset of clinical data from the prospective GammaTile clinical trial, clinical case examples of patients with recurrent meningiomas, and surgical GammaTile implant footage. Watch here

This Congress of Neurological Surgeons (CNS) webinar covers historical brain brachytherapy techniques and Surgically Targeted Radiation Therapy for brain tumors, led by Dr Clark Chen and Dr Peter Nakaji. Topics include a GammaTile Therapy technology overview, clinical data review, and single-center experience clinical case examples (CME credit is available for a fee). Watch here 

Watch an in-depth educational webinar about GammaTile Therapy, presented by world-renowned neurosurgeon Dr Joseph Zabramski and hosted by The Musella Foundation. Content includes background, safety and efficacy, surgical placement, a case study, and clinical trial information. Watch here

This American Brain Tumor Association patient webinar provides a detailed overview of surgically implanted brain tumor therapies, including GammaTile Surgically Targeted Radiation Therapy (STaRT). Dr John A. Boockvar, the director of the Brain Tumor and Pituitary/Neuroendocrine Center at Lenox Hill, discusses various treatment options, highlights their differences, and provides guidance on how patients can talk with their heath team about their care plan. Watch here

Watch a clinical abstract presentation webinar and Q&A session led by Dr Vincent DiNapoli, a neurosurgeon at Mayfield Brain & Spine in Cincinnati, Ohio. In the webinar, Dr DiNapoli presents the abstract that was accepted and scheduled to be presented at the 2020 AANS Annual Scientific Meeting. Watch here

 

Notable Clinical Publications & Awards

2020 Georgia Neurosurgical Society Annual Fall Meeting

Surgical outcomes of a novel collagen tile cesium brachytherapy for intracranial malignancy at a tertiary referral center

Andrew B. Boucher, MD; Hui-Kuo Shu MD, PhD; Jeffrey J. Olson, MD; Kimberly B. Hoang, MD. Presented at 2020 Georgia Neurosurgical Society Annual Fall Meeting; December 5, 2020. Read Abstract Text | View Abstract Presentation

Cureus 2020

Resection and surgically targeted radiation therapy for the treatment of larger recurrent or newly diagnosed brain metastasis: results from a prospective trial

Peter Nakaji, Kris Smith, Emad Youssef, Theresa Thomas, Dilini Pinnaduwage, Leland Rogers, Garrick Wallstrom, David Brachman. Cureus. 2020;12(11):e11570. Published November 19, 2020. Read here

SNO Annual Meeting 2020

A prospective trial of resection and Surgically Targeted Radiation Therapy for initial or salvage treatment of aggressive meningioma

L. Rogers, P. Nakaji, E. Youssef, K. Smith, J. Zabramski, T. Thomas, C. Dardis, D. Pinnaduwage and D. Brachman; St Joseph’s Hospital, Phoenix, AZ, Barrow Neurological Institute, Phoenix, AZ, GT Medical Technologies, Tempe, AZ. Presented November 19, 2020. Read here

CNS 2020 Virtual Meeting

Resection and surgically targeted radiation therapy for initial or salvage treatment of aggressive meningioma: results from a prospective trial

Leland Rogers, MD; Peter Nakaji, MD; Emad Youssef, MD; Kris A. Smith, MD; Joseph Zabramski, MD; Theresa Thomas, MS; Christopher Dardis, MD; Dilini Pinnaduwage, PhD; David G. Brachman, MD; St Joseph’s Hospital, Phoenix, AZ; Barrow Neurological Institute, Phoenix, AZ; GT Medical Technologies, Tempe, AZ. Presented September 30, 2020. Read here

Cureus 2020

Re-irradiation using brachytherapy for recurrent intracranial tumors: a systematic review and meta-analysis of the literature

Mehee Choi, MD; Joseph Zabramski, MD in Cureus. 12(8):e9666. Published August 11, 2020. Read here

Future Oncology 2020

GammaTile: Surgically targeted radiation therapy for glioblastomas

Dominic J. Gessler, MD; Clara Ferreira, PhD; Kathryn Dusenbery, MD; Clark C. Chen, MD in Future Oncology. 16(30). Published online July 3, 2020. Read here

SNO 2020 Virtual Conference on Brain Metastases

A prospective trial of resection plus surgically targeted radiation therapy for brain metastasis

David Brachman, MD; Peter Nakaji, MD; Kris Smith, MD; Emad Youssef, MD; Theresa Thomas, MS; Dilini Pinnaduwage, PhD; C. Leland Rogers, MD; Barrow Neurological Institute, Phoenix, AZ; GT Medical Technologies, Tempe, AZ; St Joseph’s Hospital, Phoenix, AZ. Presented August 14, 2020.  Read here

 

A randomized, multicenter phase III trial of surgery plus stereotactic radiosurgery (SRS) compared with surgery plus permanently implanted collagen tile brachytherapy (CTBT) for resectable metastatic brain tumors-protocol in progress

Jeffrey Weinberg, MD, FAANS, FACS; Hussein Tawbi, MD, PhD; Frederick Lang, MD; Jeffrey Scott Wefel, PhD, ABPP; Jason Michael Johnson, MD; Heather Lin, PhD; Ying Yuan, PhD; Mary Frances McAleer, MD, PhD. Presented August 14, 2020. Read here

Permanent intracavitary Cs131 brachytherapy for previously-irradiated recurrent brain metastases: initial clinical and radiation safety experience

Nelson S. Moss, MD; Brandon Imber, MD; Kavya Prasad, MS; Bae Chu, MPH; Arun Goel, MD; David Aramburu-Nunez, PhD; Michael Bellamy, PhD; T. Jonathan Yang, MD; Atif Khan, MD; Laurence Dauer, PhD; Gilad Cohen, MS; Kathryn Beal, MD; Viviane Tabar, MD. Presented August 14, 2020. Read here

Current Oncology Reports 2020

Evolving strategies to potentially further optimize surgical interventions in brain cancer 

Bindi B. Parikh, MD; Elizabeth C. Neil, MD in Current Oncology Reports. 22(32). Published March 6, 2020.

SNO Annual Meeting Abstract 2019

RTHP-32. First experience with gamma tile permanent implants for recurrent brain tumors 

Clara Ferreira; Parham Alaei; Clark Chen; Margaret Reynolds; David Sterling; Kathryn Dusenbery in Neuro-Oncology. 21(Supplement_6):vi216. Published November 11, 2019. Read here

American Brachytherapy Society Annual Meeting 2019

Judith Stitt Best Abstract Award winner 

Surgically targeted radiation therapy: Safety profile of collagen tile brachytherapy in 79 recurrent, previously irradiated intracranial neoplasms on a prospective clinical trial 

David Brachman, MD; Emad Youssef, MD; Christopher Dardis, MD; Kris Smith, MD; Dilini Pinnaduwage, PhD; Peter Nakaji, MD in Brachytherapy. 18(3):S35-S36. Published May 1, 2019. Read here

AANS Annual Scientific Meeting Abstracts 2019–2020

Rosenblum-Mahaley Clinical Research Award winner for the best abstract in the field of neuro-oncology 

Surgically targeted radiation therapy: a prospective trial in 79 recurrent, previously irradiated intracranial neoplasms on a prospective clinical trial

Peter Nakaji, MD, FAANS; Emad Youssef, MD; Christopher Dardis, MD; Kris Smith, MD; Dilini Pinnaduwage, PhD; David Brachman, MD. Presented April 15, 2019. Read here

Novel permanently implanted 3D-collagen tile for intraoperative brachytherapy in a patient with recurrent glioblastoma  

Vincent Anthony DiNapoli, MD; Yair Gozal, MD, PhD. Presented April 16, 2019. Read here

Journal of Neurosurgery Publication 2018

Resection and permanent intracranial brachytherapy using modular, biocompatible cesium-131 implants: results in 20 recurrent, previously irradiated meningiomas 

David G. Brachman, MD; Emad Youssef, MD; Christopher J. Dardis, MD; Nader Sanai, MD; Joseph M. Zabramski, MD; Kris A. Smith, MD; Andrew S. Little, MD; Andrew G. Shetter, MD; Theresa Thomas, MS; Heyoung L. McBride, MD, MS; Stephen Sorensen, PhD; Robert F. Spetzler, MD; Peter Nakaji, MDl in Journal of Neurosurgery. Published online December 21, 2018. Read here

White Papers

REFERENCES

  1. Nakaji P, Youssef E, Dardis C, Smith K, Pinnaduwage D, Brachman D. Surgically targeted radiation therapy: a prospective trial in 79 recurrent, previously irradiated intracranial neoplasms. Poster presented at: 2019 AANS Annual Scientific Meeting; April 2019; San Diego, CA.

  2. Armpilia CI, Dale RG, Coles IP, Jones B, Antipas V. The determination of radiobiologically optimized half-lives for radionuclides used in permanent brachytherapy implants .Int J Radiat Oncol Biol Phys. 2003;55(2):378-385.

  3. Rogers L, Nakaji P, Youssef E, et al. Resection and surgically targeted radiation therapy for initial salvage treatment of aggressive meningioma: results from a prospective trial. Presented at: CNS 2020 Virtual Meeting; September 30, 2020.

  4. Nakaji P, Smith K, Youssef E, et al. Resection and surgically targeted radiation therapy for the treatment of larger recurrent or newly diagnosed brain metastasis: results from a prospective trial. Cureus. 12(11):1-12.

  5. Data on file, GT Medical Technologies, Inc.

  6. Tsien C, Pugh S, Dicker AP, et al. Randomized phase II trial of re-irradiation and concurrent bevacizumab versus bevacizumab alone as treatment for recurrent glioblastoma (NRG Oncology/RTOG 1205): initial outcomes and RT plan quality report. International Journal of Radiation Oncology, Biology, Physics. 2019;105(1):S78.

  7. 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.

  8. Combs SE, Debus J, Schulz-Ertner D. Radiotheraputic alternatives for previously irradiated recurrent gliomas. BMC Cancer. 2007;7:167. 

  9. Wernicke AG, Smith AW, Taube S, et al. Cesium-131 brachytherapy for recurrent brain metastases: durable salvage treatment for previously irradiated metastatic disease. J Neurosurg. 2017;126(4):1212-1219. 

  10. Magill ST, Lau D, Raleigh DR, Sneed PK, Fogh SE, McDermott MW. Surgical resection and interstitial iodine-125 brachytherapy for high-grade meningiomas: a 25-year series. Neurosurgery. 2017;80(3):409-416. 

  11. Brachman D, Youssef E, Dardis C, et al. Resection and permanent intracranial brachytherapy using modular, biocompatible cesium-131 implants: results in 20 recurrent, previously irradiated meningiomas. J Neurosurg. 2019;131(6):1819-1828. 

GammaTile Therapy is indicated to deliver radiation therapy for patients with newly diagnosed malignant intracranial neoplasms and recurrent intracranial neoplasms.

 

For full safety information, refer to the GammaTile Instructions for Use.

 
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IMPROVING THE LIVES OF PATIENTS WITH BRAIN TUMORS