Intracranial MeningiomaMuRaLMNCT02974127
Multisession Radiosurgery in Large Meningiomas
An observational study of Intracranial Meningioma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Meningioma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2011to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with large or in critical site benign intracranial meningioma diagnosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, 20133
About this study
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.
Read the detailed description
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.
- Conditions
- Intracranial Meningioma
- Being tested
- Radiotherapy
- Keywords
- intracranial benign meningioma, radiosurgery, large meningioma, critical site, multisession radiosurgery
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Radiosurgery
Multisession radiosurgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation-related toxicities.
evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0
Measured: change from baseline neurological assessment at 5 years.
Local control evaluation assessed on MRI-based volumetric lesion measurements.
Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images
Measured: change from baseline volume lesion at 5 years
Secondary outcomes (5)
Neurological assessment of trigeminal pain
Evaluation based on BNP scale
Measured: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of trigeminal dysfunction
Evaluation based on BNS scale
Measured: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of facial nerve dysfunction
Evaluation based on House-Brackman scale
Measured: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of acoustic nerve dysfunction
Evaluation based on sensorineural international scale
Measured: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of visual dysfunction
Evaluation based on ophthalmological evaluation
Measured: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startAug 2011
- Primary completion30 Jun 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Fariselli, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo BEsta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974127
- Sponsor's protocol ID
- SRS_LM
- Acronym
- MuRaLM
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2016
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6.
PubMed 36075299Pinzi V, Marchetti M, De Martin E, Cuccarini V, Tramacere I, Ghielmetti F, Fumagalli ML, Iezzoni C, Fariselli L. Multisession radiosurgery for intracranial meningioma treatment: study protocol of a single arm, monocenter, prospective trial. Radiat Oncol. 2020 Jan 30;15(1):26. doi: 10.1186/s13014-020-1478-7.
PubMed 32000819
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisession Radiosurgery in Large Meningiomas
- ClinicalTrials.gov ID
- NCT02974127
- Acronym / sponsor ID
- MuRaLM / SRS_LM
- Conditions
- Intracranial Meningioma
- Keywords
- intracranial benign meningioma, radiosurgery, large meningioma, critical site, multisession radiosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with large or in critical site benign intracranial meningioma diagnosis
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: RadiosurgeryMultisession radiosurgery | Radiation | – |
Primary outcome
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
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
5 secondary outcomes
Neurological assessment of trigeminal pain
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of trigeminal dysfunction
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of facial nerve dysfunction
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of acoustic nerve dysfunction
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Neurological assessment of visual dysfunction
Time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 36075299Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6.
- Derived from this study: PubMed 32000819Pinzi V, Marchetti M, De Martin E, Cuccarini V, Tramacere I, Ghielmetti F, Fumagalli ML, Iezzoni C, Fariselli L. Multisession radiosurgery for intracranial meningioma treatment: study protocol of a single arm, monocenter, prospective trial. Radiat Oncol. 2020 Jan 30;15(1):26. doi: 10.1186/s13014-020-1478-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Fariselli, MD principal investigator
Fondazione IRCCS Istituto Neurologico Carlo BEsta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Meningioma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation-related toxicities. (time frame: change from baseline neurological assessment at 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02974127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.