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CIRSE Registry for SIR-Spheres in France (CIRT-FR)
Sponsor: Cardiovascular and Interventional Radiological Society of Europe
Summary
Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé \[HAS\]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
332
Start Date
2017-08-01
Completion Date
2022-07-31
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
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.
QLQ-C30 with HCC module
In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT-FR will incorporate a quality-of-life questionnaire. CIRT-FR 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
Locations (13)
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
Hôpital Beaujon
Clichy, France
Hôpital Henri Mondor
Créteil, France
Chu de Dijon
Dijon, France
CHU de Grenoble Alpes
Grenoble, France
Centre Léon Bérard
Lyon, France
CHU de Lyon
Lyon, France
Institut Paoli-Calmettes
Marseille, France
CHU de Nimes
Nîmes, France
Institut Gustave Roussy
Paris, France
CHU de Poitiers
Poitiers, France
CHRU de Strasbourg
Strasbourg, France