NCT03694938

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
46mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2019Feb 2030

First Submitted

Initial submission to the registry

October 2, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

11 years

First QC Date

October 2, 2018

Last Update Submit

July 16, 2025

Conditions

Metastatic Colon Cancer

Keywords

Brain metastasisMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

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

    Diagnostic of brain metastases on annual MRI

    3 years

Study Arms (1)

Magnetic resonance imaging

EXPERIMENTAL

Annual MRI during 3 years

Device: Magnetic resonance imaging

Interventions

Magnetic resonance imagingDEVICE

Annually magnetic resonance imaging

Magnetic resonance imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven colorectal adenocarcinoma
  • Metastases from colorectal cancer diagnosed since less than 6 months
  • Indication of an oncologic treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

C.H.U. d'Amiens

Amiens, 80000, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

C.H.U. de Poitiers

Poitiers, 86000, France

Location

C.H.U. de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Colonic NeoplasmsBrain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 3, 2018

Study Start

February 7, 2019

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)