Quality assurance and reporting for FLASH clinical trials: The experience of the FEATHER trial

IF 3.2 2区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

Medical physics Pub Date : 2025-09-03 DOI:10.1002/mp.18100

Isabella Colizzi, Robert Schäfer, Jonas Brückner, Gaia Dellepiane, Martin Grossmann, Maximilian Körner, Antony John Lomax, David Meer, Benno Rohrer, Carla Rohrer Bley, Michele Togno, Serena Psoroulas

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引用次数: 0

Abstract

Background

Research on ultra-high dose rate (UHDR) radiation therapy has indicated its potential to spare normal tissue while maintaining equivalent tumor control compared to conventional treatments. First clinical trials are underway. The randomized phase II/III FEATHER clinical trial at the Paul Scherrer Institute in collaboration with the University of Zurich Animal Hospital is one of the first curative domestic animal trials to be attempted, and it is designed to provide a good example for human trials. However, the lack of standardized quality assurance (QA) guidelines for FLASH clinical trials presents a significant challenge in trial design.

Purpose

This work aims to demonstrate the development and testing of QA and reporting procedures implemented in the FEATHER clinical trial.

Methods

We have expanded the clinical QA program to include UHDR-specific QA and additional patient-specific QA. Furthermore, we have modified the monitor readout to enable time-resolved measurements, allowing delivery log files to be used for dose and dose rate recalculations. Finally, we developed a reporting strategy encompassing relevant parameters for retrospective studies.

Results

We evaluated our QA and reporting procedures with simulated treatments. This testing confirmed that our QA procedures effectively ensure the correct and safe delivery of the planned dose (3%/3 mm gamma criteria, pass > 90%). Additionally, we demonstrated that we could reconstruct the delivered dose and dose rate using the delivery log files.

Conclusion

We developed and used in practice a comprehensive QA and reporting protocol for a FLASH clinical trial at the Paul Scherrer Institute. This work aims to establish guidelines and standardize reporting practices for future advancements in the FLASH-RT field.

Abstract Image

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FLASH临床试验的质量保证和报告：FEATHER试验的经验

超高剂量率（UHDR）放射治疗的研究表明，与传统治疗相比，它有可能在保留正常组织的同时保持相当的肿瘤控制。首批临床试验正在进行中。Paul Scherrer研究所与苏黎世大学动物医院合作进行的随机II/III期FEATHER临床试验是首批尝试进行的治疗性家养动物试验之一，旨在为人体试验提供一个很好的例子。然而，FLASH临床试验缺乏标准化的质量保证（QA）指南，这对试验设计提出了重大挑战。本工作旨在展示在FEATHER临床试验中实施的质量保证和报告程序的开发和测试。方法我们扩大了临床质量保证项目，包括uhdr特异性质量保证和额外的患者特异性质量保证。此外，我们修改了监视器读数，使时间分辨测量成为可能，允许递送日志文件用于剂量和剂量率的重新计算。最后，我们制定了一个包含回顾性研究相关参数的报告策略。结果：我们通过模拟治疗来评估我们的质量保证和报告程序。该测试证实，我们的QA程序有效地确保计划剂量的正确和安全交付（3%/ 3mm伽马标准，通过>； 90%）。此外，我们证明了我们可以利用传递日志文件重建传递剂量和剂量率。我们为Paul Scherrer研究所的一项FLASH临床试验制定并在实践中使用了一套全面的QA和报告方案。这项工作旨在为FLASH-RT领域的未来发展建立指导方针和标准化报告实践。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Medical physics 医学-核医学

CiteScore

6.80

自引率

15.80%

发文量

660

审稿时长

1.7 months

期刊介绍： Medical Physics publishes original, high impact physics, imaging science, and engineering research that advances patient diagnosis and therapy through contributions in 1) Basic science developments with high potential for clinical translation 2) Clinical applications of cutting edge engineering and physics innovations 3) Broadly applicable and innovative clinical physics developments Medical Physics is a journal of global scope and reach. By publishing in Medical Physics your research will reach an international, multidisciplinary audience including practicing medical physicists as well as physics- and engineering based translational scientists. We work closely with authors of promising articles to improve their quality.