Liver CancerCIRT-FRNCT03256994
CIRSE Registry for SIR-Spheres in France (CIRT-FR)
An observational study of Liver Cancer, run by Cardiovascular and Interventional Radiological Society of Europe at 13 sites in France.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Yttrium-90 loaded SIR-Spheres microspheres and QLQ-C30 with HCC module
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 332 participants
- Where
- 13 sitesFrance
- Study dates
- 1 Aug 2017to 31 Jul 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In a general manner and according to the Intent-To-Treat principle, no subject will be excluded from the analysis. The primary and secondary endpoint analysis will include all enrolled subjects in CIRT-FR. However, patients who are considered for SIR-Spheres treatment but for whom it was decided that they would not be treated will not be included in the analysis.
Who may be able to join
- 18 years or older
- Primary or secondary liver tumours
- Treatment of liver tumours with SIR-Spheres
- Signed informed consent form
Who cannot join
- Consent denied
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU d'Angers
Angers
CHU de Bordeaux
Bordeaux
Hôpital Beaujon
Clichy
Hôpital Henri Mondor
Créteil
Chu de Dijon
Dijon
CHU de Grenoble Alpes
Grenoble
Centre Léon Bérard
Lyon
CHU de Lyon
Lyon
Institut Paoli-Calmettes
Marseille
CHU de Nimes
Nîmes
Institut Gustave Roussy
Paris
CHU de Poitiers
Poitiers
CHRU de Strasbourg
Strasbourg
About this study
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.
Read the 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.
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.
The goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life, technical considerations and diagnosis and treatment-related considerations.
To better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of EORTC's validated quality of life questionnaire QLQ C30 with accompanying HCC module to measure quality of life in patients with hepatocellular carcinoma.
Besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment.
CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their treatment determined by the treating clinician. In no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.
- Conditions
- Liver Cancer
- Being tested
- Yttrium-90 loaded SIR-Spheres microspheres, QLQ-C30 with HCC module
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 loaded SIR-Spheres microspheresDevice
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 moduleBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical context in which SIR-Spheres are applied
Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
Measured: Baseline, follow-up every 3 months until 24 months
Secondary outcomes (5)
Adverse events, treatment complications and laboratory assessments
Adverse events measured according to CTCAE 4.03, treatment complications reported bz investigators and abnormal laboratory assessments according to CTCAE 4.03
Measured: Follow-up every 3 months until 24 months
Effectiveness
Based on overall survival (OS), progression free survival (PFS), liver specific PFS
Measured: Follow-up every 3 months until 24 months
QLQ-C30
Quality of life using QLQ-C30 from baseline until 24 months
Measured: Every 3 months until 24 months
Technical considerations
Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes
Measured: Baseline
Diagnosis- and treatment-related considerations
Assessed by type of liver cancer, intention of the treatment, prior hepatic procedures, associated systemic therapy and post-SIRT hepatic procedures
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie I Vilgrain, Prof, Study chair, Cardiovascular and Interventional Radiological Society of EuropeThomas I Helmberger, Prof, Study chair, Cardiovascular and Interventional Radiological Society of Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256994
- Sponsor's protocol ID
- CIRT-FR
- Acronym
- CIRT-FR
- Status last verified
- May 2026
- First submitted
- 17 Aug 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ronot M, Loffroy R, Arnold D, Greget M, Sengel C, Pinaquy JB, Pellerin O, Maleux G, Peynircioglu B, Pelage JP, Schaefer N, Sangro B, de Jong N, Zeka B, Urdaniz M, Helmberger T, Vilgrain V. Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study. Cardiovasc Intervent Radiol. 2025 Feb;48(2):205-220. doi: 10.1007/s00270-024-03955-y. Epub 2025 Jan 14.
PubMed 39809885Loffroy R, Ronot M, Greget M, Bouvier A, Mastier C, Sengel C, Tselikas L, Arnold D, Maleux G, Pelage JP, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, Urdaniz M, Kaufmann N, Bilbao JI, Helmberger T, Vilgrain V; CIRT-FR Principal Investigators. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol. 2021 Jan;44(1):36-49. doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.
PubMed 32975600Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.
PubMed 38321223Authors: Thomas Helmberger, Dirk Arnold, Romaric Loffroy, Maxime Ronot, Bruno Sangro, Frank Kolligs, Olivier Pellerin, Geert Maleux, Bora Peynircioglu, Niklaus Schaefer, Jose Ignacio Bilbao, Niels de Jong, Milan Geyer, Bleranda Zeka, Maria Urdaniz, Valerie Vilgrain Article Title: Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies Journal Name: CVIR Oncology Publication Date: 2026 Volume number: 2:5
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRSE Registry for SIR-Spheres in France (CIRT-FR)
- ClinicalTrials.gov ID
- NCT03256994
- Acronym / sponsor ID
- CIRT-FR / CIRT-FR
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of EuropeUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
The goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life, technical considerations and diagnosis and treatment-related considerations.
To better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of EORTC's validated quality of life questionnaire QLQ C30 with accompanying HCC module to measure quality of life in patients with hepatocellular carcinoma.
Besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment.
CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their treatment determined by the treating clinician. In no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In a general manner and according to the Intent-To-Treat principle, no subject will be excluded from the analysis. The primary and secondary endpoint analysis will include all enrolled subjects in CIRT-FR. However, patients who are considered for SIR-Spheres treatment but for whom it was decided that they would not be treated will not be included in the analysis.
Key inclusion criteria (4 listed)
- 18 years or older
- Primary or secondary liver tumours
- Treatment of liver tumours with SIR-Spheres
- Signed informed consent form
Key exclusion criteria (1 listed)
- Consent denied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium-90 loaded SIR-Spheres microspheresSelective 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. | Device | – |
| QLQ-C30 with HCC moduleIn 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 | Behavioural | – |
Primary outcome
Description of the clinical context in which SIR-Spheres are applied
Time frame: Baseline, follow-up every 3 months until 24 months
Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
5 secondary outcomes
Adverse events, treatment complications and laboratory assessments
Time frame: Follow-up every 3 months until 24 months
Effectiveness
Time frame: Follow-up every 3 months until 24 months
QLQ-C30
Time frame: Every 3 months until 24 months
Technical considerations
Time frame: Baseline
Diagnosis- and treatment-related considerations
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 39809885Ronot M, Loffroy R, Arnold D, Greget M, Sengel C, Pinaquy JB, Pellerin O, Maleux G, Peynircioglu B, Pelage JP, Schaefer N, Sangro B, de Jong N, Zeka B, Urdaniz M, Helmberger T, Vilgrain V. Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study. Cardiovasc Intervent Radiol. 2025 Feb;48(2):205-220. doi: 10.1007/s00270-024-03955-y. Epub 2025 Jan 14.
- Results publication: PubMed 32975600Loffroy R, Ronot M, Greget M, Bouvier A, Mastier C, Sengel C, Tselikas L, Arnold D, Maleux G, Pelage JP, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, Urdaniz M, Kaufmann N, Bilbao JI, Helmberger T, Vilgrain V; CIRT-FR Principal Investigators. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol. 2021 Jan;44(1):36-49. doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.
- Results publication: PubMed 38321223Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.
- Results publicationAuthors: Thomas Helmberger, Dirk Arnold, Romaric Loffroy, Maxime Ronot, Bruno Sangro, Frank Kolligs, Olivier Pellerin, Geert Maleux, Bora Peynircioglu, Niklaus Schaefer, Jose Ignacio Bilbao, Niels de Jong, Milan Geyer, Bleranda Zeka, Maria Urdaniz, Valerie Vilgrain Article Title: Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies Journal Name: CVIR Oncology Publication Date: 2026 Volume number: 2:5
- Individual participant dataSharing planned: No
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie I Vilgrain, Prof study chair
Cardiovascular and Interventional Radiological Society of Europe
Thomas I Helmberger, Prof study chair
Cardiovascular and Interventional Radiological Society of Europe
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Cardiovascular and Interventional Radiological Society of Europe at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the clinical context in which SIR-Spheres are applied (time frame: Baseline, follow-up every 3 months until 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256994, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.