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dc.creatorHelmberger, T. (Thomas)-
dc.creatorBilbao, J.I. (José I.)-
dc.creatorSangro, B. (Bruno)-
dc.creatorArnold, D. (Dick)-
dc.creatorJong, N. (Niels) de-
dc.creatorMaleux, G. (Geert)-
dc.creatorNordlund, A. (Anders)-
dc.creatorPeynircioglu, B. (Bora)-
dc.creatorSharma, R.A. (Ricky A.)-
dc.creatorWalk, A. (Agnes)-
dc.identifier.citationHelmberger, T. (Thomas); Bilbao, J.I. (José I.); Sangro, B. (Bruno); et al. "Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study". JMIR Research Protocols. 9 (4), 2020,es
dc.description.abstractBackground: Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. Objective: The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. Methods: Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. Results: Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. Conclusions: The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes.es_ES
dc.description.sponsorshipThis observational study was sponsored and executed by a CIRSE, as a medical society, with an unrestricted grant of the manufacturer of the SIR-Spheres 90Y resin microspheres. Thanks to the financial support from SIRTEX Medical Europe GmbH (Bonn, Germany), CIRSE was able to act as a scientifically independent sponsor of the study with sole ownership of the data. The electronic data capturing system was developed and supported by ConexSys Inc (Lincoln, RI). Necessary server infrastructure was developed and maintained by ITEA GmbH (Vienna, Austria). The authors thank the CIRSE Central Office and the staff of the CIRSE Clinical Research Department for their support during the design and the setup of the study and the drafting of the manuscript.es_ES
dc.subjectHepatocellular carcinomaes_ES
dc.subjectObservational studyes_ES
dc.subjectTherapeutic embolizationes_ES
dc.subjectRadioisotope brachytherapyes_ES
dc.titleClinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Studyes_ES
dc.description.noteThis is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.es_ES
dadun.citation.publicationNameJMIR Research Protocolses_ES

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