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Completed

NCT Number: NCT02974127

Multisession Radiosurgery in Large Meningiomas

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Milan, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Multisession radiosurgery

Other names: Radiosurgery

Primary outcomes

  1. Radiation-related toxicities.

    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

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

    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

Secondary outcomes

  1. Neurological assessment of trigeminal pain

    Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.

    Evaluation based on BNP scale

  2. Neurological assessment of trigeminal dysfunction

    Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.

    Evaluation based on BNS scale

  3. Neurological assessment of facial nerve dysfunction

    Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.

    Evaluation based on House-Brackman scale

  4. Neurological assessment of acoustic nerve dysfunction

    Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.

    Evaluation based on sensorineural international scale

  5. Neurological assessment of visual dysfunction

    Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.

    Evaluation based on ophthalmological evaluation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: MuRaLM

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Nov 28, 2016
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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