CIRSE Emprint Microwave Ablation Registry (CIEMAR)

Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Metastasis; Colorectal Neoplasms Malignant
• Intervention / Treatment: Device: Emprint Microwave Ablation System

Detailed Description

The CIRSE Emprint Microwave Ablation Registry (CIEMAR) is collecting real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System (full study duration) or Emprint HP Microwave Ablation System (from 2021 onwards).

CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study with the objective to observe the "real-life" use of MWA in Europe. The study is observing the use of the Emprint or Emprint HP Microwave Ablation System and all patients included in CIEMAR are receiving treatment with this device as their standard care for CRLM.

Primary endpoint: local tumour control in liver at 12 months after MWA on a per lesion basis

Secondary endpoints: Safety; Overall survival; Overall disease-free survival; Hepatic disease-free survival; Time to untreatable progression by thermal ablation; Systemic cancer therapy vacation; Quality of life; Adverse events and toxicity

In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with MWA, CIEMAR is collecting quality of life data using the EORTC QLQ-C30 questionnaire. 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 site and patient recruitment is complete with 500 patients from 30 sites across 11 European countries. The registry is currently collecting follow-up data (until January 2026).

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

• Study Contact: Name: Robert Bauer, MA; Phone Number: +43 1 904 2003 37; Email: bauer@cirse.org
• Study Contact Backup: Name: Daniela Schweiger, PhD; Phone Number: +43 1 904 2003 54; Email: schweiger@cirse.org

Study Locations

• Austria
  • Vienna, Austria, 1010
    • CIRSE Cardiovascular and Interventional Radiological Society of Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 18 years or older
• Proven colorectal liver metastases either histologically proven or diagnosed by imaging in a patient with known colorectal cancer
• Treated with the Emprint or Emprint HP Microwave ablation system
• Patient referred to MWA by a multidisciplinary tumour board
• Signed informed consent form
• Intention to completely treat (ablation, resection, SBRT) all visible disease within 8 weeks
• Maximum number of 9 total liver lesions
• All liver lesions must be local treatment-naive
• Maximum diameter of the largest liver lesion treated with MWA must not exceed 3cm
• Maximum diameter of lesions treated surgically may exceed this limitation
• Maximum number of 5 lung nodules eligible to be treated
• Patients may receive simultaneous liver resection and microwave ablation
• Patients may have received previous systemic therapy
• Patients must not have received surgical resection or thermal ablation for other liver lesions in the last 3 months before inclusion
• Patients treated with a liver-first approach may be included if treatment of the primary tumour is planned
• If applicable: complete response of treated rectal tumour proven by imaging

Exclusion Criteria:

• Life expectancy less than 6 months (palliative treatment)
• Extrahepatic metastases with the exception of a maximum of 5 lung nodules
• Ongoing infection (viral/bacterial)
• Patients receiving simultaneous bowel surgery and microwave ablation
• Patients receiving simultaneous IRE, RFA, SBRT, Cryoablation, HIFU or other local treatment than resection
• Pregnancy
• Patients with liver metastases that cannot be completely and safely treated
• Active cancers other than CRC
• Non-resected primary colon cancer
• Advanced liver disease or evidence of liver insufficiency

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Tumor Control	Local Tumor Control at 12 months on a per lesion basis	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE	Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.	3 years
Overall survival	Time from observation until death due to any cause (or censoring)	3 years
Overall disease-free-survival	Time from observation until disease progression or death assessed by the investigators	3 years
Hepatic disease-free-survival	Time from observation until disease progression in the liver or death assessed by the investigators.	3 years
Time to untreatable progression by thermal ablation	Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.	3 years
Systemic cancer therapy vacation	Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.	3 years
Treatment specific quality of life	Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.	1 year

Collaborators and Investigators

• Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Collaborators: Medtronic
• Investigators: Study Chair: Phillippe L. Pereira, PhD, Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany; Study Chair: Thierry de Baère, PhD, Departement of therapeutic radiology, Institut Gustave Roussy, Villejuif, France

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): January 3, 2023
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CIEMAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No