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CIRSE Registry for SIR-Spheres Therapy (CIRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Cardiovascular and Interventional Radiological Society of Europe
Sponsor:
Information provided by (Responsible Party):
Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier:
NCT02305459
First received: November 11, 2014
Last updated: November 27, 2014
Last verified: November 2014
  Purpose
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 CIRT Registry has two major objectives: 1) To collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres in a pan-European context, and 2) to collect data on the Quality of Life of patients treated with SIR-Spheres microspheres.

Condition Intervention
Liver Carcinoma
Device: Yttrium-90 loaded SIR-Spheres microspheres
Behavioral: QLQ-C30 with HCC module

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CIRSE Registry for SIR-Spheres Therapy

Resource links provided by NLM:


Further study details as provided by Cardiovascular and Interventional Radiological Society of Europe:

Primary Outcome Measures:
  • Change from Baseline in Quality of Life questionnaire QLQ-C30 with HCC Module [ Time Frame: Baseline, on average every 3 months up to 1 year ]

Estimated Enrollment: 1200
Study Start Date: November 2014
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 HCC Module to measure changes in the quality of life of the patient.

Device: Yttrium-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.
Behavioral: QLQ-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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02305459

Contacts
Contact: Niels de Jong, MA +43 1 904 2003-47 dejong@cirse.org

Locations
Austria
Cardiovascular and Interventional Radiological Society of Europe Recruiting
Vienna, Austria, 1010
Contact: Niels de Jong    +43 1 904 2003-47    dejong@cirse.org   
Contact: Robert Bauer    +43 1 904 2003-37    bauer@cirse.org   
Principal Investigator: José Bilbao, Professor         
Sponsors and Collaborators
Cardiovascular and Interventional Radiological Society of Europe
Investigators
Principal Investigator: José Ignacio Bilbao, Prof CIRSE Cardiovascular and Interventional Radiological Society of Europe
  More Information

Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier: NCT02305459     History of Changes
Other Study ID Numbers: CIRSECIRT
Study First Received: November 11, 2014
Last Updated: November 27, 2014

Keywords provided by Cardiovascular and Interventional Radiological Society of Europe:
SIRT
microcatheter
primary liver tumor
secondary liver tumor
radioembolisation
QLQ-C30
CIRSE

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on March 28, 2017