Back to resultsEvaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor (TCSEQ)
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain MRI
Sponsored by
About this trial
This is an interventional other trial for Brain Neoplasms focused on measuring Brain, Radiotherapy, MRI, Sequelae
Eligibility Criteria
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.
Sites / Locations
- Centre François Baclesse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI evaluation
Arm Description
Patient pretreated for brain tumor and witness
Outcomes
Primary Outcome Measures
Proportion of patient with MRI abnormality
To evaluate the proportion of patients with at least one abnormality on an imaging test
Secondary Outcome Measures
MRI diffusion abnormality
MRI perfusion abnormality
MRI vascular morphologic abnormalities
Full Information
NCT ID
NCT02791360
First Posted
May 17, 2016
Last Updated
January 25, 2018
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT02791360
Brief Title
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Acronym
TCSEQ
Official Title
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Brain, Radiotherapy, MRI, Sequelae
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI evaluation
Arm Type
Other
Arm Description
Patient pretreated for brain tumor and witness
Intervention Type
Other
Intervention Name(s)
Brain MRI
Primary Outcome Measure Information:
Title
Proportion of patient with MRI abnormality
Description
To evaluate the proportion of patients with at least one abnormality on an imaging test
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
MRI diffusion abnormality
Time Frame
up to 4 weeks
Title
MRI perfusion abnormality
Time Frame
up to 4 weeks
Title
MRI vascular morphologic abnormalities
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14400
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
We'll reach out to this number within 24 hrs