Standard requirements for clinical very high energy electron and ultra high dose rate medical devices
Very High-Energy Electrons (VHEE) present a promising innovation in radiation therapy (RT), particularly for the treatment of deep-seated tumors using Ultra High Dose Rate (UHDR) within the framework of FLASH-RT. VHEE offers significant advantages, such as improved tumor targeting, reduced treatment...
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Frontiers Media S.A.
2024-12-01
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphy.2024.1511830/full |
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| author | J. H. Pensavalle F. Di Martino F. Di Martino F. Di Martino A. Cavalieri M. Celentano M. Celentano A. De Gregorio A. De Gregorio M. Di Francesco G. Franciosini G. Franciosini L. Galluzzo L. Masturzo L. Masturzo G. Milluzzo P. Montay-Gruel P. Montay-Gruel F. Paiar F. Paiar F. Paiar M. Pantaleoni V. Patera V. Patera S. Pioli P. Poortmans P. Poortmans F. Romano F. Romano A. Sarti A. Sarti A. Subiel A. Subiel A. Vannozzi G. Felici |
| author_facet | J. H. Pensavalle F. Di Martino F. Di Martino F. Di Martino A. Cavalieri M. Celentano M. Celentano A. De Gregorio A. De Gregorio M. Di Francesco G. Franciosini G. Franciosini L. Galluzzo L. Masturzo L. Masturzo G. Milluzzo P. Montay-Gruel P. Montay-Gruel F. Paiar F. Paiar F. Paiar M. Pantaleoni V. Patera V. Patera S. Pioli P. Poortmans P. Poortmans F. Romano F. Romano A. Sarti A. Sarti A. Subiel A. Subiel A. Vannozzi G. Felici |
| author_sort | J. H. Pensavalle |
| collection | DOAJ |
| description | Very High-Energy Electrons (VHEE) present a promising innovation in radiation therapy (RT), particularly for the treatment of deep-seated tumors using Ultra High Dose Rate (UHDR) within the framework of FLASH-RT. VHEE offers significant advantages, such as improved tumor targeting, reduced treatment times, and potential utilization of the FLASH effect, which may minimize normal tissue toxicity. However, the lack of an international technical standard for VHEE systems, especially for UHDR applications, remains a critical challenge. Current standards for radiation therapy equipment, such as IEC 60601-2-1 and IEC 60601-2-64, do not encompass VHEE technology. This regulatory gap underscores the need for developing a structured international standard to ensure the basic safety and essential performance of VHEE medical devices. Addressing this challenge requires overcoming complex dose delivery issues, such as the interaction of multiple fields and beam conformality and incorporating novel techniques like broad beam or pencil beam scanning. Establishing comprehensive regulatory standards is essential to ensure patient safety, consistent treatment practices, and the successful clinical integration of VHEE systems. These standards must encompass design guidelines, radiation protection protocols, and integration with existing oncology practices. Collaborative research and development efforts are crucial to formulating evidence-based guidelines, fostering the safe and effective use of VHEE in clinical settings. By addressing these challenges, VHEE technology has the potential to revolutionize cancer therapy, particularly for deep-seated tumors, while enhancing therapeutic outcomes for patients. |
| format | Article |
| id | doaj-art-3473156776b640a8b8e4a51ce1e20d01 |
| institution | OA Journals |
| issn | 2296-424X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Physics |
| spelling | doaj-art-3473156776b640a8b8e4a51ce1e20d012025-08-20T01:58:22ZengFrontiers Media S.A.Frontiers in Physics2296-424X2024-12-011210.3389/fphy.2024.15118301511830Standard requirements for clinical very high energy electron and ultra high dose rate medical devicesJ. H. Pensavalle0F. Di Martino1F. Di Martino2F. Di Martino3A. Cavalieri4M. Celentano5M. Celentano6A. De Gregorio7A. De Gregorio8M. Di Francesco9G. Franciosini10G. Franciosini11L. Galluzzo12L. Masturzo13L. Masturzo14G. Milluzzo15P. Montay-Gruel16P. Montay-Gruel17F. Paiar18F. Paiar19F. Paiar20M. Pantaleoni21V. Patera22V. Patera23S. Pioli24P. Poortmans25P. Poortmans26F. Romano27F. Romano28A. Sarti29A. Sarti30A. Subiel31A. Subiel32A. Vannozzi33G. Felici34Azienda Ospedaliero Universitaria Pisa (AOUP), Fisica Sanitaria, Pisa, ItalyAzienda Ospedaliero Universitaria Pisa (AOUP), Fisica Sanitaria, Pisa, ItalyCentro Pisano Multidisciplinare Sulla Ricerca e Implementazione Clinica Della Flash Radiotherapy (CPFR@CISUP), Pisa, ItalyNational Institute of Nuclear Physics (INFN), Section of Pisa, Pisa, ItalyCenter for Instrument Sharing University of Pisa (CISUP), University of Pisa, Pisa, ItalyAzienda Ospedaliero Universitaria Pisa (AOUP), Fisica Sanitaria, Pisa, ItalyNational Institute of Nuclear Physics (INFN), Section of Pisa, Pisa, ItalyDipartimento di Fisica, Sapienza Università di Roma, Roma, ItalyIstituto Nazionale di Fisica Nucleare (INFN) Sezione di Roma I, Roma, ItalySIT Sordina IORT Technologies, Aprilia, ItalyIstituto Nazionale di Fisica Nucleare (INFN) Sezione di Roma I, Roma, ItalyDipartimento di Scienze di Base e Applicate per l’Ingegneria, Sapienza Università di Roma, Roma, ItalySIT Sordina IORT Technologies, Aprilia, ItalyAzienda Ospedaliero Universitaria Pisa (AOUP), Fisica Sanitaria, Pisa, ItalyNational Institute of Nuclear Physics (INFN), Section of Pisa, Pisa, ItalyIstituto Nazionale di Fisica Nucleare (INFN), Sezione di Catania, Catania, Italy0Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium1Iridium Netwerk, Radiation Oncology, Antwerp, BelgiumCentro Pisano Multidisciplinare Sulla Ricerca e Implementazione Clinica Della Flash Radiotherapy (CPFR@CISUP), Pisa, ItalyCenter for Instrument Sharing University of Pisa (CISUP), University of Pisa, Pisa, Italy2Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy3Maytal International Ltd – Global Med Dev Expertise, London, United KingdomIstituto Nazionale di Fisica Nucleare (INFN) Sezione di Roma I, Roma, ItalyDipartimento di Scienze di Base e Applicate per l’Ingegneria, Sapienza Università di Roma, Roma, Italy4Laboratori Nazionali Frascati-Istituto Nazionale di Fisica Nucleare (LNF-INFN), Frascati, Italy5Department of Radiation Oncology, Iridium Netwerk, Antwerp, Belgium6Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, BelgiumIstituto Nazionale di Fisica Nucleare (INFN), Sezione di Catania, Catania, Italy7Particle Therapy Research Center (PARTREC), Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, NetherlandsIstituto Nazionale di Fisica Nucleare (INFN) Sezione di Roma I, Roma, ItalyDipartimento di Scienze di Base e Applicate per l’Ingegneria, Sapienza Università di Roma, Roma, Italy8National Physical Laboratory, Teddington, London, United Kingdom9University College London, London, United Kingdom4Laboratori Nazionali Frascati-Istituto Nazionale di Fisica Nucleare (LNF-INFN), Frascati, ItalySIT Sordina IORT Technologies, Aprilia, ItalyVery High-Energy Electrons (VHEE) present a promising innovation in radiation therapy (RT), particularly for the treatment of deep-seated tumors using Ultra High Dose Rate (UHDR) within the framework of FLASH-RT. VHEE offers significant advantages, such as improved tumor targeting, reduced treatment times, and potential utilization of the FLASH effect, which may minimize normal tissue toxicity. However, the lack of an international technical standard for VHEE systems, especially for UHDR applications, remains a critical challenge. Current standards for radiation therapy equipment, such as IEC 60601-2-1 and IEC 60601-2-64, do not encompass VHEE technology. This regulatory gap underscores the need for developing a structured international standard to ensure the basic safety and essential performance of VHEE medical devices. Addressing this challenge requires overcoming complex dose delivery issues, such as the interaction of multiple fields and beam conformality and incorporating novel techniques like broad beam or pencil beam scanning. Establishing comprehensive regulatory standards is essential to ensure patient safety, consistent treatment practices, and the successful clinical integration of VHEE systems. These standards must encompass design guidelines, radiation protection protocols, and integration with existing oncology practices. Collaborative research and development efforts are crucial to formulating evidence-based guidelines, fostering the safe and effective use of VHEE in clinical settings. By addressing these challenges, VHEE technology has the potential to revolutionize cancer therapy, particularly for deep-seated tumors, while enhancing therapeutic outcomes for patients.https://www.frontiersin.org/articles/10.3389/fphy.2024.1511830/fullVHEE radiotherapyFLASH radiotherapyUHDRregulatory standardsIEC (international electrotechnical commission) |
| spellingShingle | J. H. Pensavalle F. Di Martino F. Di Martino F. Di Martino A. Cavalieri M. Celentano M. Celentano A. De Gregorio A. De Gregorio M. Di Francesco G. Franciosini G. Franciosini L. Galluzzo L. Masturzo L. Masturzo G. Milluzzo P. Montay-Gruel P. Montay-Gruel F. Paiar F. Paiar F. Paiar M. Pantaleoni V. Patera V. Patera S. Pioli P. Poortmans P. Poortmans F. Romano F. Romano A. Sarti A. Sarti A. Subiel A. Subiel A. Vannozzi G. Felici Standard requirements for clinical very high energy electron and ultra high dose rate medical devices Frontiers in Physics VHEE radiotherapy FLASH radiotherapy UHDR regulatory standards IEC (international electrotechnical commission) |
| title | Standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| title_full | Standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| title_fullStr | Standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| title_full_unstemmed | Standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| title_short | Standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| title_sort | standard requirements for clinical very high energy electron and ultra high dose rate medical devices |
| topic | VHEE radiotherapy FLASH radiotherapy UHDR regulatory standards IEC (international electrotechnical commission) |
| url | https://www.frontiersin.org/articles/10.3389/fphy.2024.1511830/full |
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