Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

Official Title ^ICMJE

Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Screening

Condition ^ICMJE

Intervention ^ICMJE

Device: Magnetic resonance imaging
Annually magnetic resonance imaging

Study Arms

Experimental: Magnetic resonance imaging
Annual MRI during 3 years

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 2024

Estimated Primary Completion Date

November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 - Pregnant or breastfeeding women, women of childbearing potential without effective contraception

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Poitiers University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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