Colorectal CarcinomaCIRELNCT03086096
CIRSE Registry for LifePearl Microspheres
An observational study of Colorectal Carcinoma and Neoplasm Metastasis, run by Cardiovascular and Interventional Radiological Society of Europe at 1 site in Austria.
Trial summary
The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Carcinoma, Neoplasm Metastasis
- What is being tested?
- LifePearl Microspheres loaded with Irinotecan
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 1 siteAustria
- Study dates
- 2 Feb 2018to 30 Apr 2022
- How long will I take part?
- 12 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
Who may be able to join
- patients with liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma
- treatment with LifePearl Microspheres
- signed informed consent form
- 18 years or older
Who cannot join
- withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
CIRSE Cardiovascular and Interventional Radiological Society of Europe
Vienna, State of Vienna, 1010
About this study
The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives:
- map the exact indications that the device is being used for and at which stage in treatment it is being applied
- to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors
Read the detailed description
CIREL will capture a broad spectrum of real clinical data on the delivery of transcatheter arterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan (LP-IRI) and the observed clinical outcomes. The aim of doing so is to improve our understanding of how LifePearl microspheres are administered as part of the standard treatment of colorectal adenocarcinoma with liver metastases in Europe. Ultimately, the collection of real-life data is intended to provide an evidence-base from which conclusions can be drawn on how to optimise treatment protocols and consequently the therapy outcome of TACE performed with LifePearl Microspheres.
The CIREL registry is a prospective multicentre observational (non-interventional) study. In order to meet the objective of collecting real-life data, all subjects receiving TACE with LifePearl Microspheres loaded with Irinotecan and fulfilling the inclusion criteria in all participating centres will be asked to participate. Patients are only asked to participate in the registry when they are treated with LifePearl Microspheres loaded with Irinotecan as part of the treatment determined by the treating clinician. In no way, will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment.
In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with LifePearl microspheres, CIREL will incorporate the EORTC QLQ-C30 questionnaire. The quality of life questionnaire is suggested to be offered to the patient at the following three points in time:
- Immediately (max. 1 week) before the treatment with LP-IRI
- 4-8 weeks after completion of the full treatment with LP-IRI
- 12-16 weeks after the completion of the full treatment with LP-IRI
Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The patient will be offered to fill out the questionnaire in his/her mother tongue. The patient will have the choice to fill in the questionnaire either in hard copy or online via the electronic data capture system.
The CIREL registry will include central image analysis performed by the Fédération Francophone de Cancérologie Digestive (FFCD). The aim of the analyis is to detect possible associations between RECIST (v1.1) criteria and observed outcomes, reduce bias by providing a second reading and raise data quality.
The registry aims at enrolling up to 150 patients. The registry will stop enrolment two and a half years after the enrolment of the first patient, unless decided differently by the Steering Committee. Patients should be followed up until 65% of active patients are deceased and for at least 12 months.
- Conditions
- Colorectal Carcinoma, Neoplasm Metastasis
- Being tested
- LifePearl Microspheres loaded with Irinotecan
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePearl Microspheres loaded with IrinotecanDevice
LifePearl Microspheres are embolisation microspheres for transcatheter chemoembolisation (TACE), that can be loaded with chemotherapeutic agents. In this registry, LifePearl Microspheres will be loaded with Irinotecan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
The primary objective is to ultimately categorise observed usages as one of the following:
- LifePearl as a first-line treatment
- LifePearl as a consolidation or closing treatment with or without systemic therapy
- Intensification of treatment with concomitant systemic therapy (objective: resectability and/or ablative therapy)
- Salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy
- Combination treatment with ablation with a curative intent
- Other
Measured: 2.5 years
Secondary outcomes (9)
Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.
Safety and Tolerability will be monitored during and after treatment with LP-IRI.
Measured: 4 years
Time from observation until death due to any cause (or censoring)
Overall survival
Measured: 4 years
Time from observation until disease progression or death
Progression-free survival (PFS) will be assessed by the investigator and central CT/MRI image analysis.
Measured: 4 years
Time from observation until disease progression in the liver or death
Hepatic progression-free survival (liver-specific PFS) will be assessed by the investigator and central CT/MRI image analysis.
Measured: 4 years
Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1)
Objective Tumour Response Rate will be assessed by the investigator and central CT/MRI image analysis.
Measured: 4 years
Number of patients with tumour shrinkage at > 20% or >30% at first tumour assessment (4 - 8 wks)
Assessment of early tumour shrinkage serves as an early-on-treatment predictor of treatment efficacy.
Measured: 4 years
Nadir of tumour response over the time of observation
Deepness of response (DpR) serves as a continuous measure, which defines the nadir of tumour response and serves as an early-on-treatment predictor of treatment efficacy.
Measured: 4 years
Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI
Secondary resection/ablation
Measured: 4 years
The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC)
Quality of Life questionnaires will be filled out:
- Baseline: maximum 1 week before the first LP-IRI treatment
- 2nd: 4-8 weeks after the whole LP-IRI treatment is completed
- 3rd: 12-16 weeks after the whole LP-IRI treatment is completed
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start2 Feb 2018
- Primary completion31 Aug 2021
- Study completion30 Apr 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 Colorectal CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Pereira, Prof., Study chair, Interventional Radiologist at SLK Klinikum Heilbronn GmbH, GermanyJulien Taieb, Prof., Study chair, Oncologist at Georges Pompidou European Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086096
- Sponsor's protocol ID
- CIREL
- Acronym
- CIREL
- Status last verified
- May 2026
- First submitted
- 1 Mar 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
Pereira PL, Iezzi R, Manfredi R, Carchesio F, Bansaghi Z, Brountzos E, Spiliopoulos S, Echevarria-Uraga JJ, Goncalves B, Inchingolo R, Nardella M, Pellerin O, Sousa M, Arnold D, de Baere T, Gomez F, Helmberger T, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann N, Taieb J. The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis. Cardiovasc Intervent Radiol. 2021 Jan;44(1):50-62. doi: 10.1007/s00270-020-02646-8. Epub 2020 Sep 24.
PubMed 32974773Pereira PL, Arnold D, de Baere T, Gomez F, Helmberger T, Iezzi R, Maleux G, Prenen H, Sangro B, Nordlund A, Zeka B, Bauer R, Kaufmann N, Pellerin O, Taieb J. A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL. Dig Liver Dis. 2020 Aug;52(8):857-861. doi: 10.1016/j.dld.2020.05.051. Epub 2020 Jun 30.
PubMed 32620520Helmberger T, Lucatelli P, Pereira PL, Gjoreski A, Jovanoska I, Bansaghi Z, Spiliopoulos S, Carchesio F, Arnold D, Baierl A, Zeka B, Kaufmann NC, Taieb J, Iezzi R. Safety, Feasibility and Technical Considerations from a Prospective, Observational Study-CIREL: Irinotecan-TACE for CRLM in 152 Patients. J Clin Med. 2022 Oct 19;11(20):6178. doi: 10.3390/jcm11206178.
PubMed 36294499Arnold D, Pereira PL, Iezzi R, Gjoreski A, Spiliopoulos S, Helmberger T, Gomez FM, de Baere T, Pellerin O, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann NC, Taieb J. Transarterial chemoembolisation with irinotecan (irinotecan-TACE) as salvage or post-inductive therapy for colorectal cancer liver metastases: effectiveness results from the CIREL study. ESMO Open. 2025 Mar;10(3):104292. doi: 10.1016/j.esmoop.2025.104292. Epub 2025 Feb 15.
PubMed 39954388
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 LifePearl Microspheres
- ClinicalTrials.gov ID
- NCT03086096
- Acronym / sponsor ID
- CIREL / CIREL
- Conditions
- Colorectal Carcinoma, Neoplasm Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of EuropeUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 22 Mar 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.
The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives:
- map the exact indications that the device is being used for and at which stage in treatment it is being applied
- to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors
Detailed description
CIREL will capture a broad spectrum of real clinical data on the delivery of transcatheter arterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan (LP-IRI) and the observed clinical outcomes. The aim of doing so is to improve our understanding of how LifePearl microspheres are administered as part of the standard treatment of colorectal adenocarcinoma with liver metastases in Europe. Ultimately, the collection of real-life data is intended to provide an evidence-base from which conclusions can be drawn on how to optimise treatment protocols and consequently the therapy outcome of TACE performed with LifePearl Microspheres.
The CIREL registry is a prospective multicentre observational (non-interventional) study. In order to meet the objective of collecting real-life data, all subjects receiving TACE with LifePearl Microspheres loaded with Irinotecan and fulfilling the inclusion criteria in all participating centres will be asked to participate. Patients are only asked to participate in the registry when they are treated with LifePearl Microspheres loaded with Irinotecan as part of the treatment determined by the treating clinician. In no way, will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment.
In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with LifePearl microspheres, CIREL will incorporate the EORTC QLQ-C30 questionnaire. The quality of life questionnaire is suggested to be offered to the patient at the following three points in time:
- Immediately (max. 1 week) before the treatment with LP-IRI
- 4-8 weeks after completion of the full treatment with LP-IRI
- 12-16 weeks after the completion of the full treatment with LP-IRI
Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The patient will be offered to fill out the questionnaire in his/her mother tongue. The patient will have the choice to fill in the questionnaire either in hard copy or online via the electronic data capture system.
The CIREL registry will include central image analysis performed by the Fédération Francophone de Cancérologie Digestive (FFCD). The aim of the analyis is to detect possible associations between RECIST (v1.1) criteria and observed outcomes, reduce bias by providing a second reading and raise data quality.
The registry aims at enrolling up to 150 patients. The registry will stop enrolment two and a half years after the enrolment of the first patient, unless decided differently by the Steering Committee. Patients should be followed up until 65% of active patients are deceased and for at least 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
Key inclusion criteria (4 listed)
- patients with liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma
- treatment with LifePearl Microspheres
- signed informed consent form
- 18 years or older
Key exclusion criteria (1 listed)
- withdrawal of informed consent
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 |
|---|---|---|
| LifePearl Microspheres loaded with IrinotecanLifePearl Microspheres are embolisation microspheres for transcatheter chemoembolisation (TACE), that can be loaded with chemotherapeutic agents. In this registry, LifePearl Microspheres will be loaded with Irinotecan. | Device | – |
Primary outcome
Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
Time frame: 2.5 years
The primary objective is to ultimately categorise observed usages as one of the following: * LifePearl as a first-line treatment * LifePearl as a consolidation or closing treatment with or without systemic therapy * Intensification of treatment with concomitant systemic therapy (objective: resectability and/or ablative therapy) * Salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy * Combination treatment with ablation with a curative intent * Other
9 secondary outcomes
Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.
Time frame: 4 years
Time from observation until death due to any cause (or censoring)
Time frame: 4 years
Time from observation until disease progression or death
Time frame: 4 years
Time from observation until disease progression in the liver or death
Time frame: 4 years
Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1)
Time frame: 4 years
Number of patients with tumour shrinkage at > 20% or >30% at first tumour assessment (4 - 8 wks)
Time frame: 4 years
Nadir of tumour response over the time of observation
Time frame: 4 years
Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI
Time frame: 4 years
The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC)
Time frame: 4 years
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 32974773Pereira PL, Iezzi R, Manfredi R, Carchesio F, Bansaghi Z, Brountzos E, Spiliopoulos S, Echevarria-Uraga JJ, Goncalves B, Inchingolo R, Nardella M, Pellerin O, Sousa M, Arnold D, de Baere T, Gomez F, Helmberger T, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann N, Taieb J. The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis. Cardiovasc Intervent Radiol. 2021 Jan;44(1):50-62. doi: 10.1007/s00270-020-02646-8. Epub 2020 Sep 24.
- Results publication: PubMed 32620520Pereira PL, Arnold D, de Baere T, Gomez F, Helmberger T, Iezzi R, Maleux G, Prenen H, Sangro B, Nordlund A, Zeka B, Bauer R, Kaufmann N, Pellerin O, Taieb J. A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL. Dig Liver Dis. 2020 Aug;52(8):857-861. doi: 10.1016/j.dld.2020.05.051. Epub 2020 Jun 30.
- Results publication: PubMed 36294499Helmberger T, Lucatelli P, Pereira PL, Gjoreski A, Jovanoska I, Bansaghi Z, Spiliopoulos S, Carchesio F, Arnold D, Baierl A, Zeka B, Kaufmann NC, Taieb J, Iezzi R. Safety, Feasibility and Technical Considerations from a Prospective, Observational Study-CIREL: Irinotecan-TACE for CRLM in 152 Patients. J Clin Med. 2022 Oct 19;11(20):6178. doi: 10.3390/jcm11206178.
- Results publication: PubMed 39954388Arnold D, Pereira PL, Iezzi R, Gjoreski A, Spiliopoulos S, Helmberger T, Gomez FM, de Baere T, Pellerin O, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann NC, Taieb J. Transarterial chemoembolisation with irinotecan (irinotecan-TACE) as salvage or post-inductive therapy for colorectal cancer liver metastases: effectiveness results from the CIREL study. ESMO Open. 2025 Mar;10(3):104292. doi: 10.1016/j.esmoop.2025.104292. Epub 2025 Feb 15.
- Individual participant dataSharing planned: No
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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.
Philippe Pereira, Prof. study chair
Interventional Radiologist at SLK Klinikum Heilbronn GmbH, Germany
Julien Taieb, Prof. study chair
Oncologist at Georges Pompidou European Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma and Neoplasm Metastasis, run by Cardiovascular and Interventional Radiological Society of Europe at 1 site in Austria.
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 1 site in Austria. 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?
Number of indications that the device is being used for, as assessed by stage and previous treatment(s) (time frame: 2.5 years). 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 NCT03086096, 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; AzTrials last refreshed its copy on 1 Nov 2026.