UnknownNot Applicable

Multisession Radiosurgery in Large Meningiomas

Italy178 participantsStarted 2011-08

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * either histologically confirmed or imaging-defined benign meningioma diagnosis; * large or medium lesion size and/or in critical area (e.i. perichiasmatic area); * signed specific informed consent; * age ≥ 18 years; * for female patients, execution of pregnancy blood test; * Karnofsky Performance Status (KPS) ≥ 70. Exclusion Criteria: * histologically confirmed diagnosis of atypical or malignant meningiomas; * patients who had received prior radiotherapy in the same site; * pregnancy; * allergy for contrast medium; * neurofibromatosis diagnosis.

What they're measuring

Radiation-related toxicities.

Timeframe: change from baseline neurological assessment at 5 years.

Local control evaluation assessed on MRI-based volumetric lesion measurements.

Timeframe: change from baseline volume lesion at 5 years

Trial details

NCT IDNCT02974127

SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More Intracranial Meningioma trials