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e-men: Embolization for Meningioma

Sponsor
St. Olavs Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05416567
Collaborator
(none)
30
Enrollment
1
Arm
180
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endovascular embolization
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Historical controls from a regional brain tumor registryHistorical controls from a regional brain tumor registry
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Therapeutic Endovascular Embolization for Intracranial Meningioma
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2037

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endovascular embolization

Procedure: Endovascular embolization
Therapeutic endovascular embolization in general anesthesia

Outcome Measures

Primary Outcome Measures

  1. Change in radiological tumor volume from baseline [At 1 year, 3 year and 5 year]

    Volumetric segmentation of tumor volume

Secondary Outcome Measures

  1. Number of participants undergoing re-intervention for meningioma or treatment complications [10 years]

    Surgery or radiotherapy

  2. Number of participants with epileptic seizures [10 years]

  3. Number of participants with moderate or severe procedure related complications within 30 days [30 days]

    Landriel Ibanez classification (grade 3 or 4 complications)

  4. Change in generic health-related quality of life from baseline [At 1 months and 6 months]

    EuroQol-5D 3L (EQ-5D 3L)

  5. Change in disease-specific quality of life from baseline [At 1 months and 6 months]

    The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

  6. Change in domain-specific quality of life from baseline [At 1 months and 6 months]

    The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire

  7. Change in neurological function [At 1 month]

    National Institutes of Health Stroke Scale (NIHSS)

  8. Number of participants with adverse events [30 days]

    Landriel Ibanez classification

  9. Number of participants returning to work [At 1 months and 6 months]

  10. Loss of functional level from baseline [At 1 month and 6 months]

    >10 points in Karnofsky performance status

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • St. Olavs Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT05416567
Other Study ID Numbers:
  • 392999
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by St. Olavs Hospital
Brain neoplasms
Therapeutics
Additional relevant MeSH terms:
Meningioma

Study Results

No Results Posted as of Jun 13, 2022