Detection of Brain Metastasis by MRI in Metastatic Colore... | NCT03694938

Studies
Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

NCT03694938

Sponsor

Poitiers University Hospital

Status

Active, not recruiting

Last Update Posted

Jul 20, 2025Actual

Enrollment

143Actual

Phase

Not Applicable

Conditions

Metastatic Colon Cancer

Interventions

Magnetic resonance imaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2019Actual

Primary Completion Date

Feb 2030Estimated

Completion Date

Feb 2030Estimated

First Submitted Date

Oct 2, 2018

First Submission Date that Met QC Criteria

Oct 2, 2018

First Posted Date

Oct 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnetic resonance imaging	Experimental	Annual MRI during 3 years	Device: Magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic resonance imaging	Device	Annually magnetic resonance imaging	Magnetic resonance imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI.	Diagnostic of brain metastases on annual MRI	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
C.H.U. d'Amiens		Amiens		80000	France
Hôpital Privé Jean Mermoz

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided