search
Back to results

Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

Primary Purpose

Metastatic Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Metastatic Colon Cancer focused on measuring Brain metastasis, Magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histologically proven colorectal adenocarcinoma
  • Metastases from colorectal cancer diagnosed since less than 6 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

Sites / Locations

  • C.H.U. d'AmiensRecruiting
  • C.H.U. de PoitiersRecruiting
  • C.H.U. de ToursRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic resonance imaging

Arm Description

Annual MRI during 3 years

Outcomes

Primary Outcome Measures

Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI.
Diagnostic of brain metastases on annual MRI

Secondary Outcome Measures

Full Information

First Posted
October 2, 2018
Last Updated
October 5, 2023
Sponsor
Poitiers University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03694938
Brief Title
Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients
Official Title
Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
February 2030 (Anticipated)
Study Completion Date
February 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer
Keywords
Brain metastasis, Magnetic resonance imaging

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic resonance imaging
Arm Type
Experimental
Arm Description
Annual MRI during 3 years
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
Annually magnetic resonance imaging
Primary Outcome Measure Information:
Title
Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI.
Description
Diagnostic of brain metastases on annual MRI
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven colorectal adenocarcinoma Metastases from colorectal cancer diagnosed since less than 6 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David TOUGERON, MD, PhD
Phone
0549443751
Ext
+33
Email
david.tougeron@chu-poitiers.fr
Facility Information:
Facility Name
C.H.U. d'Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent HAUTEFEUILLE, MD
Phone
+33322088849
Email
hautefeuille.vincent@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Vincent HAUTEFEUILLE, MD
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tougeron, MD
Email
david.tougeron@chu-poitiers.fr
Facility Name
C.H.U. de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry LECOMTE, MD
Phone
+33247475900
Email
thierry.lecomte@med.univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Thierry LECOMTE, MD

12. IPD Sharing Statement

Learn more about this trial

Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

We'll reach out to this number within 24 hrs