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Embolization for Meningioma (e-men)

Primary Purpose

Meningioma

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Endovascular embolization
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningioma focused on measuring Brain neoplasms, Therapeutics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular embolization

Arm Description

Outcomes

Primary Outcome Measures

Change in radiological tumor volume from baseline
Volumetric segmentation of tumor volume

Secondary Outcome Measures

Number of participants undergoing re-intervention for meningioma or treatment complications
Surgery or radiotherapy
Number of participants with epileptic seizures
Number of participants with moderate or severe procedure related complications within 30 days
Landriel Ibanez classification (grade 3 or 4 complications)
Change in generic health-related quality of life from baseline
EuroQol-5D 3L (EQ-5D 3L)
Change in disease-specific quality of life from baseline
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Change in domain-specific quality of life from baseline
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire
Change in neurological function
National Institutes of Health Stroke Scale (NIHSS)
Number of participants with adverse events
Landriel Ibanez classification
Number of participants returning to work
Loss of functional level from baseline
>10 points in Karnofsky performance status

Full Information

First Posted
May 9, 2022
Last Updated
October 10, 2022
Sponsor
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05416567
Brief Title
Embolization for Meningioma
Acronym
e-men
Official Title
Therapeutic Endovascular Embolization for Intracranial Meningioma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
Keywords
Brain neoplasms, Therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Historical controls from a regional brain tumor registry
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular embolization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Endovascular embolization
Intervention Description
Therapeutic endovascular embolization in general anesthesia
Primary Outcome Measure Information:
Title
Change in radiological tumor volume from baseline
Description
Volumetric segmentation of tumor volume
Time Frame
At 1 year, 3 year and 5 year
Secondary Outcome Measure Information:
Title
Number of participants undergoing re-intervention for meningioma or treatment complications
Description
Surgery or radiotherapy
Time Frame
10 years
Title
Number of participants with epileptic seizures
Time Frame
10 years
Title
Number of participants with moderate or severe procedure related complications within 30 days
Description
Landriel Ibanez classification (grade 3 or 4 complications)
Time Frame
30 days
Title
Change in generic health-related quality of life from baseline
Description
EuroQol-5D 3L (EQ-5D 3L)
Time Frame
At 1 months and 6 months
Title
Change in disease-specific quality of life from baseline
Description
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Time Frame
At 1 months and 6 months
Title
Change in domain-specific quality of life from baseline
Description
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire
Time Frame
At 1 months and 6 months
Title
Change in neurological function
Description
National Institutes of Health Stroke Scale (NIHSS)
Time Frame
At 1 month
Title
Number of participants with adverse events
Description
Landriel Ibanez classification
Time Frame
30 days
Title
Number of participants returning to work
Time Frame
At 1 months and 6 months
Title
Loss of functional level from baseline
Description
>10 points in Karnofsky performance status
Time Frame
At 1 month and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ole Solheim, PhD
Phone
+4772575256
Email
ole.solheim@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Solheim, PhD
Organizational Affiliation
St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Solheim, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Embolization for Meningioma

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