Embolization for Meningioma | NCT05416567

Studies
Embolization for Meningioma

NCT05416567

Sponsor

St. Olavs Hospital

Status

Recruiting

Last Update Posted

Jun 5, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Meningioma

Interventions

Endovascular embolization

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2022Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2037Estimated

First Submitted Date

May 9, 2022

First Submission Date that Met QC Criteria

Jun 8, 2022

First Posted Date

Jun 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endovascular embolization	Experimental		Procedure: Endovascular embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular embolization	Procedure	Therapeutic endovascular embolization in general anesthesia	Endovascular embolization

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ole Solheim, PhD	Contact	+4772575256		ole.solheim@ntnu.no

Overall Officials

Name	Affiliation	Role
Ole Solheim, PhD	St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs Hospital	Recruiting	Trondheim		7006	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008579	Meningioma
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D009380	Neoplasms, Nerve Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009383	Neoplasms, Vascular Tissue

Browse Leaves

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Browse Branches

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