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COMPLETED
NCT03256994

CIRSE Registry for SIR-Spheres in France (CIRT-FR)

Sponsor: Cardiovascular and Interventional Radiological Society of Europe

View on ClinicalTrials.gov

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

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-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