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

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.