Evidence map›Paper›PMID 40904039›Full record

ArticleMedical physics2025

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

Isabella Colizzi, Robert Schäfer, Jonas Brückner, Gaia Dellepiane, Martin Grossmann, Maximilian Körner, Antony John Lomax, David Meer, Benno Rohrer, Carla Rohrer Bley and 2 more

Abstract read
In one paragraph

Article in Medical physics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Isabella ColizziCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Robert SchäferCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Jonas BrücknerClinic for Radio-Oncology and Medical Oncology, Small Animal HospitalVetsuisse Faculty, , University of Zurich, Zurich, Switzerland.
Gaia DellepianeCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Martin GrossmannCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Maximilian KörnerClinic for Radio-Oncology and Medical Oncology, Small Animal HospitalVetsuisse Faculty, , University of Zurich, Zurich, Switzerland.
Antony John LomaxCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
David MeerCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Benno RohrerCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Carla Rohrer BleyClinic for Radio-Oncology and Medical Oncology, Small Animal HospitalVetsuisse Faculty, , University of Zurich, Zurich, Switzerland.
Michele TognoCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.
Serena PsoroulasCenter for Proton Therapy, Paul Scherrer Institut, Villigen PSI, Switzerland.

Funding

Krebsforschung KFS 5639-08-2022Swiss National Science Foundation 200882
6 · The paper itself

Abstract

backgroundResearch 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.

methodsWe 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.

resultsWe 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.

conclusionWe 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.

Indexed as

Clinical Trials as TopicQuality Assurance, Health CareAnimalsHumansQuality ControlRadiotherapy Dosageclinical trialFLASHproton therapyultra‐high dose rates

Identifiers

PMID40904039
PMCPMC12409223

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.