CIRSE Registry for SIR-Spheres Therapy

Conditions

Liver Carcinoma

Keywords

SIRT, microcatheter, primary liver tumor, secondary liver tumor, radioembolisation, QLQ-C30, CIRSE

Brief summary

The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses

Detailed description

Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.

Niklaus Schaefer, Dirk Arnold, Niels de Jong, Milan Geyer, María Urdániz et al. (6 authors)

CardioVascular and Interventional Radiology2026-05-27

10.1007/s00270-026-04483-7

Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies

T Helmberger, D. Arnold, R. Loffroy, Maxime Ronot, Bruno Sangro et al. (16 authors)

CVIR Oncology2026-03-26

10.1007/s44343-026-00035-5

Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies.

Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T.

2024-02-065 citations

10.1007/s00270-023-03657-x

Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study.

Kolligs F, Arnold D, Golfieri R, Pech M, Peynircioglu B, Pfammatter T, Ronot M, Sangro B, Schaefer N, Maleux G, Munneke G, Pereira H, Zeka B, de Jong N, Helmberger T, CIRT Principal Investigators.

2022-11-2531 citations

10.1016/j.jhepr.2022.100633

Real-world outcomes of patients with intrahepatic cholangiocarcinoma treated with trans-arterial radioembolization: Results from the CIRSE Registry for SIR-Spheres Therapy (CIRT), a large European prospective multi-center observational study.

Thomas Helmberger, Dirk Arnold, Tuğsan Ballı, Rita Golfieri, Maciej Pech et al. (8 authors)

Journal of Clinical Oncology2021-01-201 citations

10.1200/jco.2021.39.3_suppl.308

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

Romaric Loffroy, Maxime Ronot, Michel Greget, Antoine Bouvier, Charles Mastier et al. (24 authors)

CardioVascular and Interventional Radiology2020-09-2523 citations

10.1007/s00270-020-02643-x

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).

Helmberger T, Golfieri R, Pech M, Pfammatter T, Arnold D, Cianni R, Maleux G, Munneke G, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, de Jong N, Bilbao JI, On behalf of the CIRT Steering Committee, On behalf of the CIRT Principal Investigators.

2020-09-2155 citations

10.1007/s00270-020-02642-y

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

Thomas Helmberger, Dirk Arnold, José Ignacio Bilbao, Niels de Jong, Geert Maleux et al. (10 authors)

JMIR Research Protocols2020-02-2112 citations

10.2196/16296

Interventions

DEVICEYttrium-90 loaded SIR-Spheres microspheres

Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.

BEHAVIORALQLQ-C30 with HCC module

In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Treatment of liver tumour with SIR-spheres microspheres * Primary or secondary liver tumours * Signed informed consent form * 18 years or older

Exclusion criteria

* Under 18 years

Design outcomes

Primary

Measure	Time frame	Description
Description of the clinical context in which SIR-Spheres are applied	Baseline, follow-up every 3 months until 24 months	Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures

Secondary

Measure	Time frame	Description
QLQ-C30	Every 3 months until 24 months	Quality of life using QLQ-C30 from baseline until 24 months
Overall survival	Every 3 months until 24 months	Time till death
PFS	Every 3 months until 24 months	Time to progression
Hepatic PFS	Every 3 months until 24 months	Time to progression
Adverse events	Every 3 months until 24 months	Adverse events per follow-up

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORThomas Helmberger, Prof

München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München

Outcome results

None listed