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CIRSE Emprint Microwave Ablation Registry (CIEMAR)

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ClinicalTrials.gov Identifier: NCT03775980
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Cardiovascular and Interventional Radiological Society of Europe

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

Condition or disease Intervention/treatment
Colorectal Neoplasms Malignant Neoplasm Metastasis Device: Emprint Microwave Ablation System

Detailed Description:

The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System.

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 will observe the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will receive treatment with this device as their standard care for CRLM.

Primary endpoint: local tumour control in liver at 12 months after the microwave ablation treatment on a per lesion basis

Secondary objectives: 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; Economic aspects

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 will incorporate 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 registry is currently in design and it is planned to start patient inclusion in January 2020. The target is to enrol 1000 patients and patient enrolment will stop two years after the enrolment of the first patient. A follow-up period of three years has been defined by the CIEMAR Steering Committee.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: CIRSE Emprint Microwave Ablation Registry
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : July 30, 2025

Intervention Details:
  • Device: Emprint Microwave Ablation System
    Microwave Ablation of colorectal liver metastases


Primary Outcome Measures :
  1. Local Tumor Control [ Time Frame: 12 months ]
    Local Tumor Control at 12 months on a per lesion basis


Secondary Outcome Measures :
  1. Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE [ Time Frame: 3 years ]
    Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.

  2. Overall survival [ Time Frame: 3 years ]
    Time from observation until death due to any cause (or censoring)

  3. Overall disease-free-survival [ Time Frame: 3 years ]
    Time from observation until disease progression or death assessed by the investigators

  4. Hepatic disease-free-survival [ Time Frame: 3 years ]
    Time from observation until disease progression in the liver or death assessed by the investigators.

  5. Time to untreatable progression by thermal ablation [ Time Frame: 3 years ]
    Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.

  6. Systemic cancer therapy vacation [ Time Frame: 3 years ]
    Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.

  7. Treatment specific quality of life [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
Criteria

Inclusion Criteria:

  • 18 years or older
  • Proven colorectal liver metastases
  • Treated with EMPRINT Microwave ablation system.
  • Patient referred to MWA by a multidisciplinary tumour board.
  • Signed Informed consent form
  • Intention to treat all liver lesions with radical ablation
  • Intention to completely treat (ablation, resection, SABR) all visible disease
  • Maximum number of 9 liver lesions.
  • Maximum diameter of the largest liver lesion does not exceed 3 cm.
  • Maximum number of 5 lung nodules eligible to be radically treated.
  • Patients treated with a liver first approach may be included if resection of the primary tumour is planned if applicable.
  • Complete response of treated rectal tumour proven by imaging if applicable.

Exclusion Criteria:

  • Life expectancy less than 6 months (palliative treatment)
  • Extrahepatic metastases
  • Ongoing infection (viral/bacterial)
  • Pregnant women
  • 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
  • Uncorrectable coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775980


Contacts
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Contact: Robert Bauer, MA +43 1 904 2003 37 bauer@cirse.org
Contact: Daniela Schweiger, PhD +43 1 904 2003 54 schweiger@cirse.org

Locations
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Austria
CIRSE Cardiovascular and Interventional Radiological Society of Europe Recruiting
Vienna, Austria, 1010
Contact: Robert Bauer, MA       bauer@cirse.org   
Contact: Daniela Schweiger, PhD       schweiger@cirse.org   
Sponsors and Collaborators
Cardiovascular and Interventional Radiological Society of Europe
Medtronic
Investigators
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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
Additional Information:

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Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier: NCT03775980    
Other Study ID Numbers: CIEMAR
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Colorectal Neoplasms
Neoplastic Processes
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases