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

NCT03256994 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2026-05-13

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Cardiovascular and Interventional Radiological Society of Europe

    lead OTHER

Principal Investigators

  • Valérie I Vilgrain, Prof · Cardiovascular and Interventional Radiological Society of Europe

  • Thomas I Helmberger, Prof · Cardiovascular and Interventional Radiological Society of Europe

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-07-31
Completion
2022-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03256994 on ClinicalTrials.gov