Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 17, 2019
Date Accepted: Feb 21, 2020
Clinical Application of Radioembolization in Hepatic Malignancies: Study Protocol for a Prospective Multicentre Observational Study
ABSTRACT
Background:
Radioembolization, also known as trans-arterial radio-embolization (TARE) or Selective Internal Radiation Therapy (SIRT) with Yttrium-90 (90Y) resin microspheres is an established treatment modality for patients with primary and secondary liver tumours. 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 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 of age or older, receiving 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. 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, 1047 patients were included in the study. The 24-month follow-up period was ending 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 valuable insights 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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