Clinical trial · Observational
CIRSE Registry for LifePearl Microspheres
NCT03086096CI-TRIAL-00111414CIRELcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. map the exact indications that the device is being used for and at which stage in treatment it is being applied 2. to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LifePearl Microspheres loaded with Irinotecan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
- timeFrame
- 2.5 years
- description
- 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
Secondary outcomes (9)
- measure
- Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.
- timeFrame
- 4 years
- description
- Safety and Tolerability will be monitored during and after treatment with LP-IRI.
- measure
- Time from observation until death due to any cause (or censoring)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * withdrawal of informed consent
References
Publications (4)
- RESULTPereira 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. PMID 32974773
- RESULTPereira 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. PMID 32620520
- RESULTHelmberger 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. PMID 36294499
- RESULTArnold 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. PMID 39954388