Embolization for Meningioma

NCT ID: NCT05416567

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2037-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Historical controls from a regional brain tumor registry
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endovascular embolization

Group Type EXPERIMENTAL

Endovascular embolization

Intervention Type PROCEDURE

Therapeutic endovascular embolization in general anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular embolization

Therapeutic endovascular embolization in general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ole Solheim, PhD

Role: PRINCIPAL_INVESTIGATOR

St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Olavs Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ole Solheim, PhD

Role: CONTACT

+4772575256

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ole Solheim, MD, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

392999

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cryoablation of Brain Neoplasm
NCT06753617 ENROLLING_BY_INVITATION NA
Adult Intracranial Ependymoma
NCT00920335 COMPLETED NA