Meningiomae-menNCT05416567
Embolization for Meningioma
A study testing Endovascular embolization in people with Meningioma, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Endovascular embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 10 Oct 2022to Aug 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St Olavs Hospital
Trondheim, 7006
Ole Solheim, MD, PhD
About this study
Official title: Therapeutic Endovascular Embolization for Intracranial 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
- Conditions
- Meningioma
- Being tested
- Endovascular embolization
- Keywords
- Brain neoplasms, Therapeutics
- Medical subject headings
- Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular embolizationProcedure or surgery
Therapeutic endovascular embolization in general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Endovascular embolization | Experimental | Not described Receives: Procedure: Endovascular embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiological tumor volume from baseline
Volumetric segmentation of tumor volume
Measured: At 1 year, 3 year and 5 year
Secondary outcomes (10)
Number of participants undergoing re-intervention for meningioma or treatment complications
Surgery or radiotherapy
Measured: 10 years
Number of participants with epileptic seizures
Measured: 10 years
Number of participants with moderate or severe procedure related complications within 30 days
Landriel Ibanez classification (grade 3 or 4 complications)
Measured: 30 days
Change in generic health-related quality of life from baseline
EuroQol-5D 3L (EQ-5D 3L)
Measured: At 1 months and 6 months
Change in disease-specific quality of life from baseline
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Measured: At 1 months and 6 months
Change in domain-specific quality of life from baseline
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire
Measured: At 1 months and 6 months
Change in neurological function
National Institutes of Health Stroke Scale (NIHSS)
Measured: At 1 month
Number of participants with adverse events
Landriel Ibanez classification
Measured: 30 days
Number of participants returning to work
Measured: At 1 months and 6 months
Loss of functional level from baseline
>10 points in Karnofsky performance status
Measured: At 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start10 Oct 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Historical controls from a regional brain tumor registry
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole Solheim, PhD, Principal investigator, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416567
- Sponsor's protocol ID
- 392999
- Acronym
- e-men
- Status last verified
- Jul 2026
- First submitted
- 9 May 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Endovascular Embolization for Intracranial Meningioma
- ClinicalTrials.gov ID
- NCT05416567
- Acronym / sponsor ID
- e-men / 392999
- Conditions
- Meningioma
- Keywords
- Brain neoplasms, Therapeutics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2037 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Historical controls from a regional brain tumor registry
| Arm | Type | Receives |
|---|---|---|
| Endovascular embolization | Experimental | Procedure: Endovascular embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired)
- Previously treated for meningioma
- Intraosseous growth
- Tumor related brain edema
- Neurofibromatosis type 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular embolizationTherapeutic endovascular embolization in general anesthesia | Procedure or surgery | Endovascular embolization |
Primary outcome
Change in radiological tumor volume from baseline
Time frame: At 1 year, 3 year and 5 year
Volumetric segmentation of tumor volume
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole Solheim, PhD principal investigator
St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular embolization in people with Meningioma, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole Solheim, PhD (+4772575256, ole.solheim@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radiological tumor volume from baseline (time frame: At 1 year, 3 year and 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.