Embolization treatment for meningioma
Therapeutic Endovascular Embolization for Intracranial Meningioma
This study is testing a new way to treat meningioma brain tumors using a method that could help reduce bleeding during surgery and improve outcomes for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT05416567 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endovascular embolization as a treatment for meningioma, a type of brain tumor that often requires intervention when it grows or causes symptoms. The approach aims to reduce intraoperative bleeding and improve clinical outcomes for patients undergoing treatment. By assessing both radiological and clinical results, the study seeks to expand treatment options for patients with meningioma, particularly in cases where traditional surgery or radiotherapy may not be ideal. The study includes patients diagnosed with typical intracranial meningioma who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a radiological diagnosis of typical intracranial meningioma that is growing or symptomatic.
Not a fit: Patients with previous treatment for meningioma, significant tumor-related complications, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing meningioma, potentially reducing the need for invasive surgery.
How similar studies have performed: While endovascular embolization is a recognized technique in certain cases, this specific application for meningioma is less commonly studied, indicating a novel approach.
Eligibility criteria
Show full 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.
Where this trial is running
Trondheim
- St Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Ole Solheim, PhD — St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- Study coordinator: Ole Solheim, PhD
- Email: ole.solheim@ntnu.no
- Phone: +4772575256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.