Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor (TCSEQ)

January 25, 2018 updated by: Centre Francois Baclesse
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14400
        • Centre Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

In the case group:

  • A history of solid brain tumor or haematological histologically proven.
  • Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
  • Radiotherapy treatment on a tumor in place or operated.
  • Decline at least 10 years from the end of radiotherapy.
  • Treatment with isocentric conformal radiotherapy.
  • No other radiation therapy for locally recurrent brain metastases or new brain tumor.
  • Lack of known brain metastases or meningeal carcinomatosis.

For the control group:

  • Patients previously treated for cancer and disease relapse free for 10 years.
  • No brain radiotherapy treatment.
  • Lack of treatment with anti-cancer chemotherapy.
  • Women of childbearing potential must be under effective contraception.
  • Pairing according to age, sex, arms director and socio-cultural level.

For two groups:

  • Man or woman aged (e) of minimum 18 years.
  • Topic fluent French and comprising well.
  • Free and Informed Consent signed.
  • The subject should be affiliated to an appropriate social security system
  • No cons-indication to MRI.
  • The subject must have at least one primary school level

Exclusion Criteria:

In the case group:

  • Brain radiotherapy carried out by intensity modulation technique.
  • Radiation dose less than 36 Gy on the brain.
  • Subject with against-indication to MRI.

For the control group:

  • Previous history of brain radiotherapy.
  • Previous history of brain surgery.
  • Central neurological disorders, such as seizures, uncontrolled.

For two groups:

  • Current Topics in oral chemotherapy or intravenous.
  • Subject pregnant.
  • Subject is not fluent in French or including bad.
  • Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
  • Participation in a therapeutic trial for less than 30 days.
  • A person not affiliated with a social security scheme.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI evaluation
Patient pretreated for brain tumor and witness
Other: Brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patient with MRI abnormality
Time Frame: up to 4 weeks
To evaluate the proportion of patients with at least one abnormality on an imaging test
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
MRI diffusion abnormality
Time Frame: up to 4 weeks
up to 4 weeks
MRI perfusion abnormality
Time Frame: up to 4 weeks
up to 4 weeks
MRI vascular morphologic abnormalities
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCSEQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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