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

Thomas Helmberger, Dirk Arnold, José I Bilbao, Niels de Jong, Geert Maleux, Anders Nordlund, Bora Peynircioglu, Bruno Sangro, Ricky A Sharma, Agnes Walk, Thomas Helmberger, Dirk Arnold, José I Bilbao, Niels de Jong, Geert Maleux, Anders Nordlund, Bora Peynircioglu, Bruno Sangro, Ricky A Sharma, Agnes Walk

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://ichgcp.net/clinical-trials-registry/NCT02305459.

International registered report identifier (irrid): DERR1-10.2196/16296.

Keywords: hepatocellular carcinoma; liver; metastasis; observational study; radioisotope brachytherapy; registries; therapeutic embolization; yttrium-90.

Conflict of interest statement

Conflicts of Interest: Author TH received speaker honoraria from SIRTEX Medical Europe. Author DA received consulting fees and speaker honoraria from TERUMO, Boston Scientific, SIRTEX Medical Europe, and Biocompatibles. Author JB received speaker honoraria and consultation fees from SIRTEX Medical Europe. Author BS received scientific grants from Bristol-Myers-Squibb and SIRTEX Medical Europe; consultation fees and speaker honoraria from Astra Zeneca, Bayer, Bristol-Myers-Squibb, Ipsen, SIRTEX Medical Europe, and Terumo; consultation fees from Adaptimmune, BTG, Eli Lilly, and Onxeo; and fees for data review activities from Roche and BTG. Author RS received scientific grants from SIRTEX Technology and consultation fees from SIRTEX Medical Ltd. Author GM received speaker fees from SIRTEX Medical Europe. Authors NdJ, AN, BP, and AW reported no conflicts of interest.

©Thomas Helmberger, Dirk Arnold, José I Bilbao, Niels de Jong, Geert Maleux, Anders Nordlund, Bora Peynircioglu, Bruno Sangro, Ricky A Sharma, Agnes Walk. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.04.2020.

Figures

Figure 1
Figure 1
Flowchart of patient inclusion and measurement time points. CIRT: Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy.

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