Embolization for Meningioma

NCT05416567 | Recruiting

• 1 other identifier: 392999
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Meningioma

Keywords

Brain neoplasms; Therapeutics

Outcome Measures

Primary Outcomes (1)

• Change in radiological tumor volume from baseline

  Volumetric segmentation of tumor volume

  At 1 year, 3 year and 5 year

Secondary Outcomes (10)

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

  10 years

• Number of participants with epileptic seizures

  10 years

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

  30 days

• Change in generic health-related quality of life from baseline

  At 1 months and 6 months

• Change in disease-specific quality of life from baseline

  At 1 months and 6 months

Study Arms (1)

Endovascular embolization

EXPERIMENTAL

Procedure: Endovascular embolization

Interventions

Endovascular embolization PROCEDURE

Therapeutic endovascular embolization in general anesthesia

Endovascular embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St Olavs Hospital

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Meningioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ole Solheim, PhD

  St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole Solheim, PhD

CONTACT

+4772575256; ole.solheim@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Historical controls from a regional brain tumor registry

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 13, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2037
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)