Quality assuranceDesign of and technical challenges involved in a framework for multicentric radiotherapy treatment planning studies
Section snippets
Methods
For an international, multicentric in silico clinical trial that started in January 2008 a framework was built using five major action blocks (Fig. 1). A centrally hosted database (DB) was designed to host the protocol, the patient datasets, the TP results and the analysis thereof. Secure access to the database was granted to authorised project participants by means of the FTPS (secured File Transfer Protocol) and HTTPS (secured Hyper Text Transfer Protocol) protocols [8], [9]. We used Public
Quality assurance
A large collaborative project such as ROCOCO needs a well-designed data exchange set-up. Data supplied to all participants originate from multiple sources including CT, PET and MR scanners and from the TPS. TP will be based on the data available in the DB and participants will upload their data from their systems to the DB. Currently, TP has been performed using XiO/Focal (CMS Software, Elekta), Pinnacle (Philips), Virtuos/TRiP (in-house: DKFZ Heidelberg/GSI Darmstadt) and HIPLAN (in-house:
Results
The presented MISTIR framework has been successfully used for a multicentric, in silico clinical trial that is currently being conducted by the ROCOCO consortium. Twelve institutes are participating and several more have expressed interest in the study.
To ensure data integrity, a series of QA tests were performed manually on any item (including that from the host institute) that is uploaded to the DB before releasing it to the project members. The QA procedures are designed to detect and
Discussion
We have demonstrated that building a functional data management and analysis framework for an international, multicentric in silico clinical trial are feasible. Its QA procedures are able to detect data inconsistencies and prevent incorrect data analysis.
In its current state, MISTIR is used for file-based data exchange and manual data analysis. To support large multicentric trials with improved data transfer and warehousing of the DICOM RT objects and data mining capabilities we are working on
Conclusion
We presented MISTIR: a complete and secure framework for in silico clinical trials using the output of treatment planning on prepared datasets. It is successfully being used in the in silico clinical treatment planning trial that the ROCOCO consortium currently is conducting. By defining strict planning protocols and using validated algorithms, the results of the in silico trials can be used as a starting point for validating and/or generating hypotheses, without harming any patient and at a
Acknowledgments
The ROCOCO members would like to specially thank Uwe Oelfke and Wolfgang Schlegel (Deutsche Krebsforschungszentrum, Germany), Marco Schwarz (Agenzia Provinciale per la Protonterapia, Italy) and Dietmar Georg (Medizinische Universität Wien, Austria) for their initial contribution to the project. Furthermore, dosimetrists who performed treatment planning are gratefully acknowledged.
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The ROCOCO performance scoring system translates dosimetric differences into clinically relevant endpoints: Comparing IMPT to VMAT in an example pilocytic astrocytoma dataset
2021, Clinical and Translational Radiation OncologyCitation Excerpt :For OARs and CTV in each of the VMAT and IMPT plans the mean dose (Dmean), maximum dose (Dmax) and near-maximum dose (D2% or D0.1cc, the highest dose to 2% or to 0.1 cc of the volume of interest, respectively) were calculated [13]. For the hippocampus the D40% was calculated (according to Gondi et al. [14]) For statistical analysis, the previously described framework was utilised to centrally extract dose-volume-histograms (DVH) metrics from the 3D dose distributions of each single radiation treatment plan using in-house developed software in Matlab (version 2017a, The MathWorks, Natick, MA) [15]. The VMAT plan was considered the gold standard.
Association between treatment planning and delivery factors and disease progression in prostate cancer radiotherapy: Results from the TROG 03.04 RADAR trial
2018, Radiotherapy and OncologyCitation Excerpt :Furthermore, obtaining Level III randomised trial evidence for the effect of these factors is unlikely as technical modifications are introduced incrementally and uncritically [33]. Most modifications were introduced in response to successful planning dosimetry studies [1] for immediate improvement of treatment quality. This study therefore provides much needed evidence of the actual clinical impact of these modifications.
Benefit of particle therapy in re-irradiation of head and neck patients. Results of a multicentric in silico ROCOCO trial
2016, Radiotherapy and OncologyCitation Excerpt :The datasets were stored and exchanged through the secured collaborative MISTIR platform (www.mistir.info) hosted by MAASTRO clinic. Quality assurance procedures were applied to assess the necessity of corrections of transformations during treatment planning system (TPS) import and export [39]. Matlab software (The Math Works, Natick, MA) was used for statistical analysis.
The INTEGRATE project: Delivering solutions for efficient multi-centric clinical research and trials
2016, Journal of Biomedical InformaticsCitation Excerpt :There is a strong need to integrate the available data and knowledge in comprehensive models supported by interoperable infrastructures and tools, to standardize methodologies, and to achieve wide-scale data sharing and reuse, and multidisciplinary collaboration. It is therefore becoming critical that several IT solutions need to be in place, while novel concepts are also necessary for facilitating security, recruitment and execution of such trials including quality control [11]. The INTEGRATE project proposed and implemented a technological environment based on the following methodological principles:
Implementation of a software for REmote COMparison of PARticlE and photon treatment plans: ReCompare
2015, Zeitschrift fur Medizinische Physik
- 1
Present address: Westdeutsches Protonentherapiezentrum Essen (WPE), Germany.
- 2
These authors contributed equally to this work.
- 3
On behalf of the ROCOCO consortium: JL Habrand, A Mazal (Centre de Protontherapie d’Orsay, FR); AE Nahum (Clatterbridge Centre for Oncology, UK); G Iancu, M Krämer, M Scholz (Gesellschaft für Schwerionenforschung, DE); J Debus, O Jäkel (Heidelberger Ionenstrahl-Therapiezentrum, DE); BG Baumert, AL Dekker, D De Ruysscher, P Lambin, LC Persoon, M Pijls-Johannesma, E Roelofs, F Verhaegen (MAASTRO clinic, NL); M Engelsman (Massachusetts General Hospital and Harvard Medical School, USA); M Baba, T Hirohiko, N Kanematsu (National Institute of Radiological Sciences, JA); CR Rasch, M Verheij, LJ Zijp (Netherlands Cancer Institute, NL); A Lomax, JM Schippers (Paul Scherrer Institut, CH); M Eble (University Hospital Aachen, DE); F Ammazzalorso, U Jelen (University Hospital Giessen and Marburg); M Coghe, G De Meerleer, W De Neve, V Fonteyne, I Madani (University Hospital Ghent, BE); JA Langendijk, C Schilstra, TA van de Water (University Medical Center Groningen, NL).