Embolization for Meningioma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05416567
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

St. Olavs Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ole Solheim, PhD
Principal Investigator Affiliation St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Meningioma
Arms & Interventions

Arms

Experimental: Endovascular embolization

Interventions

Procedure: - Endovascular embolization

Therapeutic endovascular embolization in general anesthesia

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

St Olavs Hospital, Trondheim, Norway

Status

Recruiting

Address

St Olavs Hospital

Trondheim, , 7006

Site Contact

Ole Solheim, MD, PhD

[email protected]

+4772575256

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