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NCT Number: NCT05416567

Embolization for Meningioma

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

Recruiting

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Key information

Conditions

Meningioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Meningeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, 7006, Norway

Location status: Recruiting

Location contact

Ole Solheim, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Endovascular embolization

Procedure

Therapeutic endovascular embolization in general anesthesia

Primary outcomes

  1. Change in radiological tumor volume from baseline

    Time frame: At 1 year, 3 year and 5 year

    Volumetric segmentation of tumor volume

Secondary outcomes

  1. Number of participants undergoing re-intervention for meningioma or treatment complications

    Time frame: 10 years

    Surgery or radiotherapy

  2. Number of participants with epileptic seizures

    Time frame: 10 years

  3. Number of participants with moderate or severe procedure related complications within 30 days

    Time frame: 30 days

    Landriel Ibanez classification (grade 3 or 4 complications)

  4. Change in generic health-related quality of life from baseline

    Time frame: At 1 months and 6 months

    EuroQol-5D 3L (EQ-5D 3L)

  5. Change in disease-specific quality of life from baseline

    Time frame: At 1 months and 6 months

    The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

  6. Change in domain-specific quality of life from baseline

    Time frame: At 1 months and 6 months

    The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire

  7. Change in neurological function

    Time frame: At 1 month

    National Institutes of Health Stroke Scale (NIHSS)

  8. Number of participants with adverse events

    Time frame: 30 days

    Landriel Ibanez classification

  9. Number of participants returning to work

    Time frame: At 1 months and 6 months

  10. Loss of functional level from baseline

    Time frame: At 1 month and 6 months

    >10 points in Karnofsky performance status

Study contacts

Contact information is provided by the study sponsor or research team.

Ole Solheim, PhD

CONTACT

[email protected]

+4772575256

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

Therapeutic Endovascular Embolization for Intracranial Meningioma

Acronym: e-men

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
Jun 13, 2022
Registry last updated
Jul 21, 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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