Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, 20133, Italy
NCT Number: NCT02974127
This is a prospective observational trial consisting of robotic multisession radiosurgery (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.
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Notify Me18 year–80 year
All sexes
Observational
Milan, 20133, Italy
To date, the treatment of choice for intracranial meningiomas is surgical removal.
Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. Despite being a well-established treatment for intracranial meningiomas, SRS might be associated with significant morbidity when large volumes or critical sites are treated. Hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity.
The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment).
The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0 and BPN BSN House-Brackman and sensorineural internation scale assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multisession radiosurgery
Other names: Radiosurgery
Time frame: change from baseline neurological assessment at 5 years.
evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0
Time frame: change from baseline volume lesion at 5 years
Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Evaluation based on BNP scale
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Evaluation based on BNS scale
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Evaluation based on House-Brackman scale
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Evaluation based on sensorineural international scale
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Evaluation based on ophthalmological evaluation
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
Acronym: MuRaLM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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