Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Not Applicable
Completed
- Conditions
- Brain Neoplasms
- Interventions
- Other: Brain MRI
- Registration Number
- NCT02791360
- Lead Sponsor
- Centre Francois Baclesse
- Brief Summary
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI evaluation Brain MRI Patient pretreated for brain tumor and witness
- Primary Outcome Measures
Name Time Method Proportion of patient with MRI abnormality up to 4 weeks To evaluate the proportion of patients with at least one abnormality on an imaging test
- Secondary Outcome Measures
Name Time Method MRI diffusion abnormality up to 4 weeks MRI perfusion abnormality up to 4 weeks MRI vascular morphologic abnormalities up to 4 weeks
Trial Locations
- Locations (1)
Centre François Baclesse
🇫🇷Caen, France