Evidence map›Paper›PMID 33816251›Full record

ArticleFrontiers in oncology2021

A Modular System for Treating Moving Anatomical Targets With Scanned Ion Beams at Multiple Facilities: Pre-Clinical Testing for Quality and Safety of Beam Delivery.

Michelle Lis, Wayne Newhauser, Marco Donetti, Moritz Wolf, Timo Steinsberger, Athena Paz, Marco Durante, Christian Graeff

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. 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
1.6field-weighted citation impact, top 18% of its field
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, 6 citations in OpenAlex.

  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

8 authors at 4 institutions in 3 countries.

Michelle LisBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
Wayne NewhauserDepartment of Physics and Astronomy, Louisiana State University, Baton Rouge, LA, United States.
Marco DonettiResearch and Development Department, Centro Nazionale di Androterapia Oncologia, Pavia, Italy.
Moritz WolfBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
Timo SteinsbergerBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
Athena PazBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
Marco DuranteBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
Christian GraeffBiophysics, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany.
GSI Helmholtz Centre for Heavy Ion Research · DELouisiana State University · USNational Center for Oncological Hadrontherapy · ITTechnical University of Darmstadt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuality management and safety are integral to modern radiotherapy. New radiotherapy technologies require new consensus guidelines on quality and safety. Established analysis strategies, such as the failure modes and effects analysis (FMEA) and incident learning systems have been developed as tools to assess the safety of several types of radiation therapies. An extensive literature documents the widespread application of risk analysis methods to photon radiation therapy. Relatively little attention has been paid to performing risk analyses of nascent radiation therapy systems to treat moving tumors with scanned heavy ion beams. The purpose of this study was to apply a comprehensive safety analysis strategy to a motion-synchronized dose delivery system (M-DDS) for ion therapy.

methodsWe applied a risk analysis method to new treatment planning and treatment delivery processes with scanned heavy ion beams. The processes utilize a prototype, modular dose delivery system, currently undergoing preclinical testing, that provides new capabilities for treating moving anatomy. Each step in the treatment process was listed in a process map, potential errors for each step were identified and scored using the risk probability number in an FMEA, and the possible causes of each error were described in a fault tree analysis. Solutions were identified to mitigate the risk of these errors, including permanent corrective actions, periodic quality assurance (QA) tests, and patient specific QA (PSQA) tests. Each solution was tested experimentally.

resultsThe analysis revealed 58 potential errors that could compromise beam delivery quality or safety. Each of the 14 binary (pass-or-fail) tests passed. Each of the nine QA and four PSQA tests were within anticipated clinical specifications. The modular M-DDS was modified accordingly, and was found to function at two centers.

conclusionWe have applied a comprehensive risk analysis strategy to the M-DDS and shown that it is a clinically viable motion mitigation strategy. The described strategy can be utilized at any ion therapy center that operates with the modular M-DDS. The approach can also be adapted for use at other facilities and can be combined with existing safety analysis systems.

Indexed as

4D therapycarbon ion therapyfailure modes and effects analysismotion-mitigationmotion-synchronized dose deliverypatient safetyquality assurance

Identifiers

PMID33816251
PMCPMC8018284
OpenAlexW3137419589

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.