Informations générales (source: ClinicalTrials.gov)
MEningioma Detection Using Non Contrast MRI TecHniquEs (MENTHE)
Observational
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
juin 2020
juin 2027
29 juin 2024
Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for
35% of central nervous system tumors, and its incidence is estimated at 3% in large
autopsy series.
The current gold standard for screening and monitoring cerebral meningiomas is MRI with
injection of gadoline-contrast product. However, the use of some of these products is
problematic, due to gadolinium deposits observed in patients who have had several
injections during their lifetime, especially in patients followed for multiple sclerosis.
Recently, the French National Agency for the Safety of Medicines and Health Products
(ANSM) issued recommendations concerning the screening of meningiomas in patients at
risk, particularly in people treated with cyproterone acetate. It is a synthetic
progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic
syndromes in women or in the palliative treatment of prostate cancer in men. Its
long-term use seems to be associated with a significant over-risk of developing
meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in
women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of
60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM
recommends that a cerebral MRI be performed at the beginning of treatment for all
patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI
at 5 years is normal. These recommendations will lead to a large number of MRIs involving
an injection of contrast agent in this population, with potential immediate or delayed
serious adverse effects.
New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized
for contrast detection, have been developed. These could detect meningeal anomalies and
more particularly meningiomas without contrast injection, or with a significantly lower
dose of contrast agent.
These techniques have not been specifically studied for screening or monitoring meningeal
lesions, but it seems relevant and important to be able to validate protocols that reduce
gadolinium doses given the high number of screening and follow-up MRIs in the general
population.
Patients presenting for brain MRI for meningioma screening or follow-up will have the
usual MRI sequences for their management, and the FABIR sequences without injection,
added for research. These new sequences will add approximately 8 minutes of additional
examination time.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Augustin LECLER | 21/06/2024 13:32:58 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- Patient over 18 years of age
- Patient performing MRI as part of a screening or follow-up of known meningioma
- Express consent to participate in the study
- Patient over 18 years of age
- Patient performing MRI as part of a screening or follow-up of known meningioma
- Express consent to participate in the study
- Contraindication for MRI (electrical device, metallic foreign body, claustrophobia)
- Known hypersensitivity to the contrast medium (Gadolinium)
- Known renal failure: glomerular filtration rate <30mL/min
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman