Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT06036706
Eligibility Criteria:
Patients:
Inclusion Criteria:
* Benign meningioma (grade I), or atypical meningioma (grade II)
* Histologic proven of benign meningioma, atypical meningioma or unequivocal radiological diagnosis of skull base meningioma if biopsy is recused.
* Indication of irradiation validated by a multidisciplinary meeting
* Age \>20 years and \<65 years
* Expected overall survival \>10 years
* Adjuvant or exclusive irradiation is allowed.
* Signed informed consent form
* WHO Performance status equal to 0 or 1
* Patient affiliated to the French social health insurance
* Patient whose neuropsychological abilities allow to follow the requirements of the protocol
Exclusion Criteria:
* Patient with mutation in a known predisposition gene (NF-2, SMARCE-1).
* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia.
* Other localization than skull base meningioma
* Histology/radiological features rather different than grade I-II meningioma
* Histologic proven grade III meningioma
* Uncontrolled epilepsy
* Contraindication to MRI
* Patient with a history of brain irradiation.
* Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)
* Pregnant/breastfeeding woman
* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study
* Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug or combination for less than 30 days
* Patient deprived of freedom or under guardianship
* Hypersensibility to Gadolinium
Participants free of brain disease or cancer history:
Inclusion Criteria:
* Subject without any history of neurological disease (cerebral stroke, epilepsy, Intra cranial Neurosurgery procedure, meningioma, pituitary adenoma, Parkinson disease,Dementia…) or absence of personality disorders and progressive psychiatric pathology
* Age \>20 years and \<65 years
* Signed informed consent form
* WHO Performance status equal to 0 or 1
* Subject affiliated to the French social health insurance
* Subject whose neuropsychological abilities allow to follow the requirements of the protocol
* No major cognitive disorder that may compromise the realization of cognitive evaluations, defined as a MoCA score in accordance with the threshold depending on age and educational level according to the GRECOGVASC normative data
Non-inclusion criteria
* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia
* History of epilepsy with antiepileptic drug
* Subject with a history of brain irradiation
* Subject with a history of cancer in the last five years (Excluding skin baso-cellular carcinoma)
* Pregnant/breastfeeding woman
* Any geographical conditions, social and associated psychopathology that may compromise the subject's ability to participate in the study
* Participation in a therapeutic trial - Subject deprived of freedom or under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06036706
Study Brief:
Protocol Section:
NCT06036706