Health TrialsbyHealthPanel

Embolization for Meningioma

ConditionMeningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired)

Previously treated for meningioma

Intraosseous growth

Tumor related brain edema

Trial design

Design model

Single group

Treatments tested in this trial

  • Endovascular embolization

    Procedure/Surgery

    Therapeutic endovascular embolization in general anesthesia

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Endovascular embolizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in radiological tumor volume from baseline

Volumetric segmentation of tumor volume

Time frame
At 1 year, 3 year and 5 year

Secondary outcomes

1

Number of participants undergoing re-intervention for meningioma or treatment complications

Surgery or radiotherapy

Time frame
10 years
2

Number of participants with epileptic seizures

Time frame
10 years
3

Number of participants with moderate or severe procedure related complications within 30 days

Landriel Ibanez classification (grade 3 or 4 complications)

Time frame
30 days
4

Change in generic health-related quality of life from baseline

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

Time frame
At 1 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Source ClinicalTrials.gov
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