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New treatment option for Meningioma
Official title Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
ClinicalTrials.gov ID: NCT06036706
What this study is testing
- What it's testing
- For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 65
You may be able to join if
- Patients:
- 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
You likely can't join if
- 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...
- Other localization than skull base meningioma
- Histology/radiological features rather different than grade I-II meningioma
- Histologic proven grade III meningioma
- Uncontrolled epilepsy
See the full eligibility criteria
- Patients:
- 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Le Havre, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Le Havre, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.