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Recruiting NCT05416567

Embolization for Meningioma

No phase Interventional Meningioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular embolization.
Who it may be relevant to
Registry conditions: Meningioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Therapeutic Endovascular Embolization for Intracranial Meningioma

Overview

The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma

Interventions

  • Procedure Endovascular embolization
    Therapeutic endovascular embolization in general anesthesia

Primary outcome measures

  • Change in radiological tumor volume from baseline [Time frame: At 1 year, 3 year and 5 year]
Secondary outcome measures (10)
  • Number of participants undergoing re-intervention for meningioma or treatment complications [Time frame: 10 years]
  • Number of participants with epileptic seizures [Time frame: 10 years]
  • Number of participants with moderate or severe procedure related complications within 30 days [Time frame: 30 days]
  • Change in generic health-related quality of life from baseline [Time frame: At 1 months and 6 months]
  • Change in disease-specific quality of life from baseline [Time frame: At 1 months and 6 months]
  • Change in domain-specific quality of life from baseline [Time frame: At 1 months and 6 months]
  • Change in neurological function [Time frame: At 1 month]
  • Number of participants with adverse events [Time frame: 30 days]
  • Number of participants returning to work [Time frame: At 1 months and 6 months]
  • Loss of functional level from baseline [Time frame: At 1 month and 6 months]

Eligibility criteria

Inclusion criteria

  • Radiological diagnose of typical intracranial meningioma (homogenous contrast enhancement or dural attachment)
  • Indication for treatment due to growth, symptoms or both
  • Tumor location suggestive of vascular supply via middle meningeal artery branches
  • Age 18 years or older
  • Karnofsky performance status of 90 or better (able to carry on normal activity and work)

Exclusion criteria

  • Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired)
  • Previously treated for meningioma
  • Intraosseous growth
  • Tumor related brain edema
  • Neurofibromatosis type 2
  • Systemic cancer
  • Epilepsy
  • Progressive neurodegenerative disorder (eg. MS, Parkinsons disease)
  • History of psychiatric disorder
  • Unfit for participation for any other reason judged by the physician including patients
  • Contraindications to MRI
  • Allergic to contrast agents
  • Relative contraindications to endovascular treatment judged from CT angiography (tortoise carotid arteries, carotid stenosis, calcified aortic arch, anatomical vascular variants/anomalies suggesting increased risk with endovascular treatment)
  • DSA (Digital subtraction angiography) from carotid artery suggesting that significant vascular supply is from other vessels than the MMA.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • St Olavs Hospital — Trondheim

Identifiers

NCT: NCT05416567 · 392999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗