First clinical implementation of GammaTile permanent brain implants after FDA clearance

Clara Ferreira; David Sterling; Margaret Reynolds; Kathryn Dusenbery; Clark Chen; Parham Alaei

doi:10.1016/j.brachy.2020.12.005

First clinical implementation of GammaTile permanent brain implants after FDA clearance

Clara Ferreira, David Sterling, Margaret Reynolds, Kathryn Dusenbery, Clark Chen, Parham Alaei

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Purpose: GammaTile cesium-131 (¹³¹Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain tumors. Our center was the first institution in the United States after FDA clearance to offer the clinical use of GammaTile brachytherapy outside of a clinical trial. The purpose of this work is to aid the medical physicist and radiation oncologist in implementing this collagen carrier tile brachytherapy (CTBT) program in their practice. Methods: A total of 23 patients have been treated with GammaTile to date at our center. Treatment planning system (TPS) commissioning was performed by configuring the parameters for the ¹³¹Cs (IsoRay Model CS-1, Rev2) source, and doses were validated with the consensus data from the American Association of Physicists in Medicine TG-43U1S2. Implant procedures, dosimetry, postimplant planning, and target delineations were established based on our clinical experience. Radiation safety aspects were evaluated based on exposure rate measurements of implanted patients, as well as body and ring badge measurements. Results: An estimated timeframe of the GammaTile clinical responsibilities for the medical physicist, radiation oncologist, and neurosurgeon is presented. TPS doses were validated with published dose to water for ¹³¹Cs. Clinical aspects, including estimation of the number of tiles, treatment planning, dosimetry, and radiation safety considerations, are presented. Conclusion: The implementation of the GammaTile program requires collaboration from multiple specialties, including medical physics, radiation oncology, and neurosurgery. This manuscript provides a roadmap for the implementation of this therapy.

Original language	English (US)
Pages (from-to)	673-685
Number of pages	13
Journal	Brachytherapy
Volume	20
Issue number	3
DOIs	https://doi.org/10.1016/j.brachy.2020.12.005
State	Published - May 1 2021

Bibliographical note

Funding Information:
The authors would like to thank the University of Minnesota radiation safety department for their support, Dr. Edward Dunham and Kate Bak for help on the manuscript revisions, and Dr. David Brachman and Dr. Adam Turner for additional technical details provided. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Publisher Copyright:
© 2020 The Authors

Keywords

Brain cancer
Cesium-131
Collagen carrier tile brachytherapy (CTBT)
GammaTile

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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@article{d0a99e46f1954b058fd78dc18503df30,

title = "First clinical implementation of GammaTile permanent brain implants after FDA clearance",

abstract = "Purpose: GammaTile cesium-131 (131Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain tumors. Our center was the first institution in the United States after FDA clearance to offer the clinical use of GammaTile brachytherapy outside of a clinical trial. The purpose of this work is to aid the medical physicist and radiation oncologist in implementing this collagen carrier tile brachytherapy (CTBT) program in their practice. Methods: A total of 23 patients have been treated with GammaTile to date at our center. Treatment planning system (TPS) commissioning was performed by configuring the parameters for the 131Cs (IsoRay Model CS-1, Rev2) source, and doses were validated with the consensus data from the American Association of Physicists in Medicine TG-43U1S2. Implant procedures, dosimetry, postimplant planning, and target delineations were established based on our clinical experience. Radiation safety aspects were evaluated based on exposure rate measurements of implanted patients, as well as body and ring badge measurements. Results: An estimated timeframe of the GammaTile clinical responsibilities for the medical physicist, radiation oncologist, and neurosurgeon is presented. TPS doses were validated with published dose to water for 131Cs. Clinical aspects, including estimation of the number of tiles, treatment planning, dosimetry, and radiation safety considerations, are presented. Conclusion: The implementation of the GammaTile program requires collaboration from multiple specialties, including medical physics, radiation oncology, and neurosurgery. This manuscript provides a roadmap for the implementation of this therapy.",

keywords = "Brain cancer, Cesium-131, Collagen carrier tile brachytherapy (CTBT), GammaTile",

author = "Clara Ferreira and David Sterling and Margaret Reynolds and Kathryn Dusenbery and Clark Chen and Parham Alaei",

note = "Funding Information: The authors would like to thank the University of Minnesota radiation safety department for their support, Dr. Edward Dunham and Kate Bak for help on the manuscript revisions, and Dr. David Brachman and Dr. Adam Turner for additional technical details provided. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: {\textcopyright} 2020 The Authors",

year = "2021",

month = may,

day = "1",

doi = "10.1016/j.brachy.2020.12.005",

language = "English (US)",

volume = "20",

pages = "673--685",

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T1 - First clinical implementation of GammaTile permanent brain implants after FDA clearance

AU - Ferreira, Clara

AU - Sterling, David

AU - Reynolds, Margaret

AU - Dusenbery, Kathryn

AU - Chen, Clark

AU - Alaei, Parham

N1 - Funding Information: The authors would like to thank the University of Minnesota radiation safety department for their support, Dr. Edward Dunham and Kate Bak for help on the manuscript revisions, and Dr. David Brachman and Dr. Adam Turner for additional technical details provided. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2020 The Authors

PY - 2021/5/1

Y1 - 2021/5/1

N2 - Purpose: GammaTile cesium-131 (131Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain tumors. Our center was the first institution in the United States after FDA clearance to offer the clinical use of GammaTile brachytherapy outside of a clinical trial. The purpose of this work is to aid the medical physicist and radiation oncologist in implementing this collagen carrier tile brachytherapy (CTBT) program in their practice. Methods: A total of 23 patients have been treated with GammaTile to date at our center. Treatment planning system (TPS) commissioning was performed by configuring the parameters for the 131Cs (IsoRay Model CS-1, Rev2) source, and doses were validated with the consensus data from the American Association of Physicists in Medicine TG-43U1S2. Implant procedures, dosimetry, postimplant planning, and target delineations were established based on our clinical experience. Radiation safety aspects were evaluated based on exposure rate measurements of implanted patients, as well as body and ring badge measurements. Results: An estimated timeframe of the GammaTile clinical responsibilities for the medical physicist, radiation oncologist, and neurosurgeon is presented. TPS doses were validated with published dose to water for 131Cs. Clinical aspects, including estimation of the number of tiles, treatment planning, dosimetry, and radiation safety considerations, are presented. Conclusion: The implementation of the GammaTile program requires collaboration from multiple specialties, including medical physics, radiation oncology, and neurosurgery. This manuscript provides a roadmap for the implementation of this therapy.

AB - Purpose: GammaTile cesium-131 (131Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain tumors. Our center was the first institution in the United States after FDA clearance to offer the clinical use of GammaTile brachytherapy outside of a clinical trial. The purpose of this work is to aid the medical physicist and radiation oncologist in implementing this collagen carrier tile brachytherapy (CTBT) program in their practice. Methods: A total of 23 patients have been treated with GammaTile to date at our center. Treatment planning system (TPS) commissioning was performed by configuring the parameters for the 131Cs (IsoRay Model CS-1, Rev2) source, and doses were validated with the consensus data from the American Association of Physicists in Medicine TG-43U1S2. Implant procedures, dosimetry, postimplant planning, and target delineations were established based on our clinical experience. Radiation safety aspects were evaluated based on exposure rate measurements of implanted patients, as well as body and ring badge measurements. Results: An estimated timeframe of the GammaTile clinical responsibilities for the medical physicist, radiation oncologist, and neurosurgeon is presented. TPS doses were validated with published dose to water for 131Cs. Clinical aspects, including estimation of the number of tiles, treatment planning, dosimetry, and radiation safety considerations, are presented. Conclusion: The implementation of the GammaTile program requires collaboration from multiple specialties, including medical physics, radiation oncology, and neurosurgery. This manuscript provides a roadmap for the implementation of this therapy.

KW - Brain cancer

KW - Cesium-131

KW - Collagen carrier tile brachytherapy (CTBT)

KW - GammaTile

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First clinical implementation of GammaTile permanent brain implants after FDA clearance

Abstract

Bibliographical note

Keywords

UN SDGs

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