Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03694938
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Poitiers University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Colon Cancer
Arms & Interventions

Arms

Experimental: Magnetic resonance imaging

Annual MRI during 3 years

Interventions

Device: - Magnetic resonance imaging

Annually magnetic resonance imaging

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

C.H.U. d'Amiens, Amiens, France

Status

Recruiting

Address

C.H.U. d'Amiens

Amiens, , 80000

Site Contact

Vincent HAUTEFEUILLE, MD

[email protected]

+33322088849

C.H.U. de Poitiers, Poitiers, France

Status

Recruiting

Address

C.H.U. de Poitiers

Poitiers, , 86000

Site Contact

David Tougeron, MD

[email protected]

0549443751

C.H.U. de Tours, Tours, France

Status

Recruiting

Address

C.H.U. de Tours

Tours, , 37044

Site Contact

Thierry LECOMTE, MD

[email protected]

+33247475900

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