ClinicalTrials.gg
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

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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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

In context

Meningioma

255 studies on the registry are indexed under Meningioma; 85 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 180 interventional studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • performance status of 90 or better (able to carry on normal activity and work)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

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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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Aug 2027, 58 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2022
First posted
Jun 13, 2022
StartActual
Oct 10, 2022
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2037
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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