Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
All Genders
NCT06036706

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

Age: 20Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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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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