Clinical trial NCT05416567: Embolization for Meningioma
Official title: Therapeutic Endovascular Embolization for Intracranial Meningioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meningioma
Keywords: Brain neoplasms
Therapeutics
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Historical controls from a regional brain tumor registry
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in radiological tumor volume from baseline
timeFrame: At 1 year, 3 year and 5 year
Secondary outcomes:
measure: Number of participants undergoing re-intervention for meningioma or treatment complications
timeFrame: 10 years
measure: Number of participants with epileptic seizures
timeFrame: 10 years
measure: Number of participants with moderate or severe procedure related complications within 30 days
timeFrame: 30 days
measure: Change in generic health-related quality of life from baseline
timeFrame: At 1 months and 6 months
measure: Change in disease-specific quality of life from baseline
timeFrame: At 1 months and 6 months
measure: Change in domain-specific quality of life from baseline
timeFrame: At 1 months and 6 months
measure: Change in neurological function
timeFrame: At 1 month
measure: Number of participants with adverse events
timeFrame: 30 days
measure: Number of participants returning to work
timeFrame: At 1 months and 6 months
measure: Loss of functional level from baseline
timeFrame: At 1 month and 6 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
name: Ole Solheim, PhD
role: PRINCIPAL_INVESTIGATOR
References: