Actively Recruiting
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
Led by Centre Francois Baclesse · Updated on 2025-06-24
108
Participants Needed
3
Research Sites
820 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
R
Région Normandie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.
CONDITIONS
Official Title
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of benign (grade I) or atypical (grade II) meningioma confirmed by histology or clear radiological evidence if biopsy is declined
- Planned irradiation treatment approved by a multidisciplinary team
- Age between 20 and 65 years
- Expected survival of more than 10 years
- Receiving adjuvant or exclusive irradiation treatment
- Signed informed consent
- WHO Performance status 0 or 1
- Affiliated with French social health insurance
- Neuropsychological abilities adequate to follow study requirements
You will not qualify if you...
- Mutation in known predisposition genes (NF-2, SMARCE-1)
- Presence of cerebrovascular disease, other nervous system tumors, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (except dementia), or schizophrenia
- Meningioma located outside the skull base
- Histology or radiological features inconsistent with grade I-II meningioma
- Histologically confirmed grade III meningioma
- Uncontrolled epilepsy
- Contraindications to MRI
- History of brain irradiation
- History of cancer within the last five years (except skin baso-cellular carcinoma)
- Pregnant or breastfeeding women
- Geographic, social, or psychiatric conditions that could affect study participation
- Participation in another therapeutic trial involving radiotherapy or new drugs for less than 30 days
- Deprivation of liberty or under guardianship
- Hypersensitivity to Gadolinium
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Trial Site Locations
Total: 3 locations
1
centre François Baclesse
Caen, France, 14000
Actively Recruiting
2
Centre Guillaume le Conquérant
Le Havre, France
Not Yet Recruiting
3
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
Research Team
J
Jeanne RIVERAIN, MD
CONTACT
J
Jean-Michel GRELLARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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