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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02791360
Acronym
TCSEQ
Enrollment
15
Registered
2016-06-06
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

Brain, Radiotherapy, MRI, Sequelae

Brief summary

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

Interventions

OTHERBrain MRI

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patient with MRI abnormalityup to 4 weeksTo evaluate the proportion of patients with at least one abnormality on an imaging test

Secondary

MeasureTime frame
MRI diffusion abnormalityup to 4 weeks
MRI perfusion abnormalityup to 4 weeks
MRI vascular morphologic abnormalitiesup to 4 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026