Clinical trial · Observational
Multisession Radiosurgery in Large Meningiomas
NCT02974127CI-TRIAL-00124846MuRaLMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Meningioma | Intracranial Meningioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Radiation-related toxicities.
- timeFrame
- change from baseline neurological assessment at 5 years.
- description
- evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0
- measure
- Local control evaluation assessed on MRI-based volumetric lesion measurements.
- timeFrame
- change from baseline volume lesion at 5 years
- description
- Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images
Secondary outcomes (5)
- measure
- Neurological assessment of trigeminal pain
- timeFrame
- every 6 months, up to 3 years. Afterwards, every year up to 5 years.
- description
- Evaluation based on BNP scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDPinzi 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. PMID 36075299
- DERIVEDPinzi 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. PMID 32000819