A roadmap to clinical trials for FLASH Review


Authors: Taylor, P. A.; Moran, J. M.; Jaffray, D. A.; Buchsbaum, J. C.
Review Title: A roadmap to clinical trials for FLASH
Abstract: While FLASH radiation therapy is inspiring enthusiasm to transform the field, it is neither new nor well understood with respect to the radiobiological mechanisms. As FLASH clinical trials are designed, it will be important to ensure we can deliver dose consistently and safely to every patient. Much like hyperthermia and proton therapy, FLASH is a promising new technology that will be complex to implement in the clinic and similarly will require customized credentialing for multi-institutional clinical trials. There is no doubt that FLASH seems promising, but many technologies that we take for granted in conventional radiation oncology, such as rigorous dosimetry, 3D treatment planning, volumetric image guidance, or motion management, may play a major role in defining how to use, or whether to use, FLASH radiotherapy. Given the extended time frame for patients to experience late effects, we recommend moving deliberately but cautiously forward toward clinical trials. In this paper, we review the state of quality assurance and safety systems in FLASH, identify critical pre-clinical data points that need to be defined, and suggest how lessons learned from previous technological advancements will help us close the gaps and build a successful path to evidence-driven FLASH implementation. © 2022 The Authors. Medical Physics published by Wiley Periodicals LLC on behalf of American Association of Physicists in Medicine.
Keywords: adult; clinical trial; treatment planning; conference paper; quality control; radiotherapy; oncology; radiation oncology; dosimetry; quality assurance; radiation therapy; motion; clinical trials; high dose rate; proton therapy; hyperthermia therapy; preclinical study; human; 3d treatment planning; advanced technology; roadmap; radiobiological mechanism; flash; ultra-high dose rate; ultra-high
Journal Title: Medical Physics
Volume: 49
Issue: 6
ISSN: 0094-2405
Publisher: American Association of Physicists in Medicine  
Date Published: 2022-06-01
Start Page: 4099
End Page: 4108
Language: English
DOI: 10.1002/mp.15623
PUBMED: 35366339
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 1 July 2022 -- Source: Scopus
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  1. Jean Marie Moran
    48 Moran