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Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694938
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.

Condition or disease Intervention/treatment Phase
Metastatic Colon Cancer Device: Magnetic resonance imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnetic resonance imaging
Annual MRI during 3 years
Device: Magnetic resonance imaging
Annually magnetic resonance imaging




Primary Outcome Measures :
  1. Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI. [ Time Frame: 3 years ]
    Diagnostic of brain metastases on annual MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven colorectal adenocarcinoma
  • Metastases from colorectal cancer diagnosed since less than 3 months
  • Indication of an oncologic treatment

Exclusion Criteria:

  • Patient with contraindication for MRI
  • Diagnosis of cancer other than colorectal cancer in the last three years, except in situ cancers, basal-cell skin cancer or squamous-cell skin cancer, and other cancer with low risk of brain dissemination according to the investigator
  • Pregnant or breastfeeding women, women of childbearing potential without effective contraception

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): NCT03694938


Contacts
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Contact: David TOUGERON, MD, PhD 0549443751 ext +33 david.tougeron@chu-poitiers.fr

Locations
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France
C.H.U. de Poitiers Recruiting
Poitiers, France, 86000
Contact: David Tougeron, MD       david.tougeron@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03694938    
Other Study ID Numbers: DEMECIA
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
Brain metastasis
Magnetic resonance imaging
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes