CIRSE Registry for SIR-Spheres Therapy (CIRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02305459|
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment|
|Liver Carcinoma||Device: Yttrium-90 loaded SIR-Spheres microspheres Behavioral: QLQ-C30 with HCC module|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1200 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||CIRSE Registry for SIR-Spheres Therapy|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305459
|Contact: Niels de Jong, MA||+43 1 904 email@example.com|
|Cardiovascular and Interventional Radiological Society of Europe||Recruiting|
|Vienna, Austria, 1010|
|Contact: Niels de Jong +43 1 904 2003-47 firstname.lastname@example.org|
|Contact: Robert Bauer +43 1 904 2003-37 email@example.com|
|Principal Investigator: José Bilbao, Professor|
|Principal Investigator:||José Ignacio Bilbao, Prof||CIRSE Cardiovascular and Interventional Radiological Society of Europe|