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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with Radioembolisation | All Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment. 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 the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 loaded SIR-Spheres microspheres | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the clinical context in which SIR-Spheres are applied | Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures | Baseline, follow-up every 3 months until 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events per follow-up | Every 3 months until 24 months |
| QLQ-C30 | Quality of life using QLQ-C30 from baseline until 24 months |
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Inclusion Criteria:
Exclusion criteria
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Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of the treatment determined by the treating clinician.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Helmberger, Prof | München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular and Interventional Radiological Society of Europe | Vienna | 1010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38321223 | Result | 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. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6. | |
| 36270925 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| QLQ-C30 with HCC module | Behavioral | 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. |
|
| Every 3 months until 24 months |
| Overall survival | Time till death | Every 3 months until 24 months |
| PFS | Time to progression | Every 3 months until 24 months |
| Hepatic PFS | Time to progression | Every 3 months until 24 months |
| Result |
| Schaefer N, Grozinger G, Pech M, Pfammatter T, Soydal C, Arnold D, Kolligs F, Maleux G, Munneke G, Peynircioglu B, Sangro B, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT. Clin Colorectal Cancer. 2022 Dec;21(4):285-296. doi: 10.1016/j.clcc.2022.09.002. Epub 2022 Sep 20. |
| 36914788 | Result | Maleux G, Albrecht T, Arnold D, Bargellini I, Cianni R, Helmberger T, Kolligs F, Munneke G, Peynircioglu B, Sangro B, Schaefer N, Pereira H, Zeka B, de Jong N, Bilbao JI; CIRT Principal Investigators. Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study. Cardiovasc Intervent Radiol. 2023 Jul;46(7):852-867. doi: 10.1007/s00270-023-03391-4. Epub 2023 Mar 13. |
| 36593888 | Result | 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. Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study. JHEP Rep. 2022 Nov 25;5(2):100633. doi: 10.1016/j.jhepr.2022.100633. eCollection 2023 Feb. |
| 32959085 | Result | 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. 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). Cardiovasc Intervent Radiol. 2021 Jan;44(1):21-35. doi: 10.1007/s00270-020-02642-y. Epub 2020 Sep 21. |
| 32319960 | Result | Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A. Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Apr 22;9(4):e16296. doi: 10.2196/16296. |
| Result | Authors: Thomas Helmberger, Dirk Arnold, Romaric Loffroy, Maxime Ronot, Bruno Sangro, Frank Kolligs, Olivier Pellerin, Geert Maleux, Bora Peynircioglu, Niklaus Schaefer, Jose Ignacio Bilbao, Niels de Jong, Milan Geyer, Bleranda Zeka, Maria Urdaniz, Valerie Vilgrain Article Title: Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies Journal Name: CVIR Oncology Publication Date: 2026 Volume number: 2:5 . : . . |
| 42203908 | Derived | Schaefer N, Arnold D, de Jong N, Geyer M, Urdaniz M, Helmberger T. Aspartate Aminotransferase to Platelet Index (APRI) as a Prognostic Factor for Overall Survival After TARE Y90 Resin Microspheres in Primary Liver Cancer Patients: Results from the European, Prospective Observational Study CIRT. Cardiovasc Intervent Radiol. 2026 May 27. doi: 10.1007/s00270-026-04483-7. Online ahead of print. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |