Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study

Abstract

Background 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. Trial Registration ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459 International Registered Report Identifier (IRRID) DERR1-10.2196/16296

Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT)

“…Cox multiple regression is used to assess the impact of the covariates for OS and hazard ratios (HR), 95% CI and p -values are provided for all covariates. Covariates were chosen prior to data analysis and were published in a methodology manuscript [ 37 ]. P -values of < 0.05 are considered statistically significant.…”

Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France

“…This study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines and was approved by the CPP SUD-EST II French Ethics Committee (N°ID-RCB: 2017-A01003-50). Since this study is an offspring of the European observational study CIRT [9] and closely corresponds to its methodology, please refer to the published methodology of CIRT for a more detailed description of methods and outcome measures [8].…”

“…CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France; NCT03256994) was developed as a France-only adaptation of the pan-European, prospective observational study CIRT (NCT02305459) [8]. While CIRT [9] had only collected data from one French hospital, CIRT-FR was open to all French centres and designed to exhaustively include as many patients in France as possible.…”

Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT

“…CIRT is a prospective, single device, multicentre observational study of patients with primary and metastatic hepatic malignancies treated with TARE with Y90 resin microspheres as the standard of care. The CIRT methodology was published by Helmberger et al (21). Sites were invited to participate if they had reported to have at least 40 TARE cases overall and ten cases in the twelve months prior to invitation.…”

“…Detailed information concerning the timing of assessments can be found in Helmberger et al, 2020 [21].…”