CIRSE Registry for LifePearl Microspheres

NCT03086096 | Completed DMC

• 1 other identifier: 2
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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. 1.map the exact indications that the device is being used for and at which stage in treatment it is being applied
2. 2.to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors

Conditions

Colorectal Carcinoma; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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

  2.5 years

Secondary Outcomes (9)

• Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.

  4 years

• Time from observation until death due to any cause (or censoring)

  4 years

• Time from observation until disease progression or death

  4 years

• Time from observation until disease progression in the liver or death

  4 years

• Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1)

  4 years

Interventions

LifePearl Microspheres loaded with Irinotecan DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease

You may qualify if:

• patients with liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma
• treatment with LifePearl Microspheres
• signed informed consent form
• years or older

You may not qualify if:

• withdrawal of informed consent

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead

Study Sites (1)

CIRSE Cardiovascular and Interventional Radiological Society of Europe

Vienna, 1010, Austria

Location

Related Publications (2)

• 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.

  PMID: 32974773 DERIVED

• Pereira 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Pereira, Prof.

  Interventional Radiologist at SLK Klinikum Heilbronn GmbH, Germany

  STUDY CHAIR

• Julien Taieb, Prof.

  Oncologist at Georges Pompidou European Hospital, Paris, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 22, 2017
• Study Start: February 2, 2018
• Primary Completion: August 31, 2021
• Study Completion: April 30, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)