Embolization for Meningioma

Meningioma Clinical Trial

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Official title:

Therapeutic Endovascular Embolization for Intracranial Meningioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416567
• Other study ID #: 392999
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: August 2037

Study information

• Verified date: October 2022
• Source: St. Olavs Hospital
• Contact: Ole Solheim, PhD
• Phone: +4772575256
• Email: ole.solheim[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2037
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meningioma

Intervention

Procedure:
• Endovascular embolization
Therapeutic endovascular embolization in general anesthesia

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in radiological tumor volume from baseline	Volumetric segmentation of tumor volume	At 1 year, 3 year and 5 year
Secondary	Number of participants undergoing re-intervention for meningioma or treatment complications	Surgery or radiotherapy	10 years
Secondary	Number of participants with epileptic seizures		10 years
Secondary	Number of participants with moderate or severe procedure related complications within 30 days	Landriel Ibanez classification (grade 3 or 4 complications)	30 days
Secondary	Change in generic health-related quality of life from baseline	EuroQol-5D 3L (EQ-5D 3L)	At 1 months and 6 months
Secondary	Change in disease-specific quality of life from baseline	The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire	At 1 months and 6 months
Secondary	Change in domain-specific quality of life from baseline	The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire	At 1 months and 6 months
Secondary	Change in neurological function	National Institutes of Health Stroke Scale (NIHSS)	At 1 month
Secondary	Number of participants with adverse events	Landriel Ibanez classification	30 days
Secondary	Number of participants returning to work		At 1 months and 6 months
Secondary	Loss of functional level from baseline	>10 points in Karnofsky performance status	At 1 month and 6 months