Embolization for Meningioma (e-men)

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

Study Overview

• Status: Recruiting
• Conditions: Meningioma
• Intervention / Treatment: Procedure: Endovascular embolization

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ole Solheim, PhD; Phone Number: +4772575256; Email: ole.solheim@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • Recruiting
    • St Olavs Hospital
    • Contact: Ole Solheim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular embolization	Procedure: Endovascular embolization; Therapeutic endovascular embolization in general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in radiological tumor volume from baseline	Volumetric segmentation of tumor volume	At 1 year, 3 year and 5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants undergoing re-intervention for meningioma or treatment complications	Surgery or radiotherapy	10 years
Number of participants with epileptic seizures		10 years
Number of participants with moderate or severe procedure related complications within 30 days	Landriel Ibanez classification (grade 3 or 4 complications)	30 days
Change in generic health-related quality of life from baseline	EuroQol-5D 3L (EQ-5D 3L)	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	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	At 1 months and 6 months
Change in neurological function	National Institutes of Health Stroke Scale (NIHSS)	At 1 month
Number of participants with adverse events	Landriel Ibanez classification	30 days
Number of participants returning to work		At 1 months and 6 months
Loss of functional level from baseline	>10 points in Karnofsky performance status	At 1 month and 6 months

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Principal Investigator: Ole Solheim, PhD, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): August 1, 2037

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Therapeutics; Brain neoplasms
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma
• Other Study ID Numbers: 392999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No