Intra-operative electron radiation therapy (IOeRT) is a clinical technique for delivering high-dose radiation directly to the tumour bed in a single fraction during surgery. Recent advancements in radiobiological research led to FLASH radiation therapy (FLASH-RT), characterized by ultra-highdose-rate (UHDR) irradiation (>40 Gy/s), being demonstrated having the potential to significantly widen the therapeutic window by reducing normal tissue toxicity while preserving tumour control. IOeRT using electrons represents a uniquely suitable clinical application of FLASH thanks to its intrinsic alignment with critical FLASH criteria, easily satisfying the conditions present in pre-clinical in vivo studies on different animal models, including low energy electrons, dose delivered in a single fraction, average dose-rate >40 Gy/s and total irradiation time <0.1 s. This comprehensive document proposes essential considerations, technical guidelines, and regulatory frameworks that are crucial for designing, verifying, and clinically implementing FLASH-IOeRT devices. It emphasizes the necessity to extend international standards, specifically IEC 60601-2-1, to accommodate the increasing demands of UHDR electron beams, thus paving the way for broader clinical adoption and enhancing patient outcomes.
Basic Safety and Essential Performance for FLASH-IOeRT
Alessio Milanesi;
2025-01-01
Abstract
Intra-operative electron radiation therapy (IOeRT) is a clinical technique for delivering high-dose radiation directly to the tumour bed in a single fraction during surgery. Recent advancements in radiobiological research led to FLASH radiation therapy (FLASH-RT), characterized by ultra-highdose-rate (UHDR) irradiation (>40 Gy/s), being demonstrated having the potential to significantly widen the therapeutic window by reducing normal tissue toxicity while preserving tumour control. IOeRT using electrons represents a uniquely suitable clinical application of FLASH thanks to its intrinsic alignment with critical FLASH criteria, easily satisfying the conditions present in pre-clinical in vivo studies on different animal models, including low energy electrons, dose delivered in a single fraction, average dose-rate >40 Gy/s and total irradiation time <0.1 s. This comprehensive document proposes essential considerations, technical guidelines, and regulatory frameworks that are crucial for designing, verifying, and clinically implementing FLASH-IOeRT devices. It emphasizes the necessity to extend international standards, specifically IEC 60601-2-1, to accommodate the increasing demands of UHDR electron beams, thus paving the way for broader clinical adoption and enhancing patient outcomes.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
