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RecruitingNCT05416567e-menUpdated Jul 21, 2026

Embolization for Meningioma

An interventional study of Endovascular embolization in Meningioma, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Meningioma

Keywords

  • Brain neoplasms
  • Therapeutics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Endovascular embolization

    Procedure: Endovascular embolization

Interventions

  • ProcedureEndovascular embolization

    Therapeutic endovascular embolization in general anesthesia

05

What researchers measure

Primary outcomes

  1. Change in radiological tumor volume from baseline

    Volumetric segmentation of tumor volume

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

Secondary outcomes

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

    Surgery or radiotherapy

    Time frame: 10 years

  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

    Landriel Ibanez classification (grade 3 or 4 complications)

    Time frame: 30 days

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

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

    Time frame: At 1 months and 6 months

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

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

    Time frame: At 1 months and 6 months

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

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

    Time frame: At 1 months and 6 months

  7. Change in neurological function

    National Institutes of Health Stroke Scale (NIHSS)

    Time frame: At 1 month

  8. Number of participants with adverse events

    Landriel Ibanez classification

    Time frame: 30 days

  9. Number of participants returning to work

    Time frame: At 1 months and 6 months

  10. Loss of functional level from baseline

    \>10 points in Karnofsky performance status

    Time frame: At 1 month and 6 months

06

Study locations

1 of 1 sites recruiting
  • St Olavs Hospital
    Trondheim, 7006, Norway
    • Ole Solheim, MD, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05416567
Lead sponsor
St. Olavs Hospital
Responsible party
Sponsor
First posted
Jun 13, 2022
Start date
Oct 10, 2022
Primary completion
Aug 2027 (estimated)
Completion
Aug 2037 (estimated)
Last update
Jul 21, 2026

Study contacts

Ole Solheim, PhD
Contact
ole.solheim@ntnu.no
+4772575256
Ole Solheim, PhD
principal investigator · St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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