Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT02305459
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2014-11-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CIRSE Registry for SIR-Spheres Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1051}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-11-27', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the clinical context in which SIR-Spheres are applied', 'timeFrame': 'Baseline, follow-up every 3 months until 24 months', 'description': 'Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Every 3 months until 24 months', 'description': 'Adverse events per follow-up'}, {'measure': 'QLQ-C30', 'timeFrame': 'Every 3 months until 24 months', 'description': 'Quality of life using QLQ-C30 from baseline until 24 months'}, {'measure': 'Overall survival', 'timeFrame': 'Every 3 months until 24 months', 'description': 'Time till death'}, {'measure': 'PFS', 'timeFrame': 'Every 3 months until 24 months', 'description': 'Time to progression'}, {'measure': 'Hepatic PFS', 'timeFrame': 'Every 3 months until 24 months', 'description': 'Time to progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SIRT', 'microcatheter', 'primary liver tumor', 'secondary liver tumor', 'radioembolisation', 'QLQ-C30', 'CIRSE'], 'conditions': ['Liver Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38321223', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36593888', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32959085', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32319960', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment of liver tumour with SIR-spheres microspheres\n* Primary or secondary liver tumours\n* Signed informed consent form\n* 18 years or older\n\nExclusion criteria\n\n* Under 18 years'}, 'identificationModule': {'nctId': 'NCT02305459', 'acronym': 'CIRT', 'briefTitle': 'CIRSE Registry for SIR-Spheres Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular and Interventional Radiological Society of Europe'}, 'officialTitle': 'CIRSE Registry for SIR-Spheres Therapy', 'orgStudyIdInfo': {'id': 'CIRSECIRT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Radioembolisation', 'description': "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.\n\nIn 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.", 'interventionNames': ['Device: Yttrium-90 loaded SIR-Spheres microspheres', 'Behavioral: QLQ-C30 with HCC module']}], 'interventions': [{'name': 'Yttrium-90 loaded SIR-Spheres microspheres', 'type': 'DEVICE', '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. SIR-Spheres microspheres are manufactured by Sirtex Medical.', 'armGroupLabels': ['Patients treated with Radioembolisation']}, {'name': 'QLQ-C30 with HCC module', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Patients treated with Radioembolisation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1010', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Cardiovascular and Interventional Radiological Society of Europe', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Thomas Helmberger, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular and Interventional Radiological Society of Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}