Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 17, 2019
Date Accepted: Feb 21, 2020
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Prospective Multicentre Observational Study on Radioembolization with 90Y Resin Microspheres: The CIRT (CIRSE Registry for SIR-Spheres Therapy) Study Protocol
ABSTRACT
Background:
Radioembolization, also known as trans-arterial radio-embolization (TARE) or Selective Internal Radiation Therapy (SIRT) with Yttrium-90 (90Y) resin microspheres is a well-studied treatment modality for patients with primary and secondary liver tumours and is used in clinical practice. Large-scale prospective observational data on the application of this treatment in the real-life clinical setting is lacking.
Objective:
The main objective is to collect data on the clinical application of radioembolization to improve the understanding of the impact of this treatment modality in its true clinical setting.
Methods:
Eligible patients are 18 years of age or older, treated with radioembolization for primary and secondary liver tumours as part of routine practice and have signed informed consent. Data is collected at baseline, right after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the CIRSE Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization and the impact of the treatment in clinical practice. Secondary objectives include safety, effectiveness in terms of overall survival (OS), progression-free survival (PFS), liver-specific PFS, imaging response and change in quality of life (QoL).
Results:
Between January 2015 and December 2017, 1050 patients were included in the study. The 24-month follow-up period will end in December 2019. The first results will be expected in the third quarter of 2020.
Conclusions:
The CIRT is the largest observational study on radioembolization to date and will provide a valuable understanding to the clinical application of this treatment modality and its real-life outcomes. Clinical Trial: CIRSE Registry for SIR-Spheres Therapy (CIRT) NCT02305459 https://clinicaltrials.gov/ct2/show/NCT02305459
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