Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-04 @ 5:36 AM
Study NCT ID:
NCT05416567
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embolization for Meningioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Historical controls from a regional brain tumor registry'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2037-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in radiological tumor volume from baseline', 'timeFrame': 'At 1 year, 3 year and 5 year', 'description': 'Volumetric segmentation of tumor volume'}], 'secondaryOutcomes': [{'measure': 'Number of participants undergoing re-intervention for meningioma or treatment complications', 'timeFrame': '10 years', 'description': 'Surgery or radiotherapy'}, {'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', 'description': 'Landriel Ibanez classification (grade 3 or 4 complications)'}, {'measure': 'Change in generic health-related quality of life from baseline', 'timeFrame': 'At 1 months and 6 months', 'description': 'EuroQol-5D 3L (EQ-5D 3L)'}, {'measure': 'Change in disease-specific quality of life from baseline', 'timeFrame': 'At 1 months and 6 months', 'description': 'The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire'}, {'measure': 'Change in domain-specific quality of life from baseline', 'timeFrame': 'At 1 months and 6 months', 'description': 'The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire'}, {'measure': 'Change in neurological function', 'timeFrame': 'At 1 month', 'description': 'National Institutes of Health Stroke Scale (NIHSS)'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '30 days', 'description': 'Landriel Ibanez classification'}, {'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', 'description': '\\>10 points in Karnofsky performance status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain neoplasms', 'Therapeutics'], 'conditions': ['Meningioma']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiological diagnose of typical intracranial meningioma (homogenous contrast enhancement or dural attachment)\n* Indication for treatment due to growth, symptoms or both\n* Tumor location suggestive of vascular supply via middle meningeal artery branches\n* Age 18 years or older\n* Karnofsky performance status of 90 or better (able to carry on normal activity and work)\n\nExclusion Criteria:\n\n* Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired)\n* Previously treated for meningioma\n* Intraosseous growth\n* Tumor related brain edema\n* Neurofibromatosis type 2\n* Systemic cancer\n* Epilepsy\n* Progressive neurodegenerative disorder (eg. MS, Parkinsons disease)\n* History of psychiatric disorder\n* Unfit for participation for any other reason judged by the physician including patients\n* Contraindications to MRI\n* Allergic to contrast agents\n* 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)\n* DSA (Digital subtraction angiography) from carotid artery suggesting that significant vascular supply is from other vessels than the MMA.'}, 'identificationModule': {'nctId': 'NCT05416567', 'acronym': 'e-men', 'briefTitle': 'Embolization for Meningioma', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Therapeutic Endovascular Embolization for Intracranial Meningioma', 'orgStudyIdInfo': {'id': '392999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endovascular embolization', 'interventionNames': ['Procedure: Endovascular embolization']}], 'interventions': [{'name': 'Endovascular embolization', 'type': 'PROCEDURE', 'description': 'Therapeutic endovascular embolization in general anesthesia', 'armGroupLabels': ['Endovascular embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ole Solheim, MD, PhD', 'role': 'CONTACT'}], 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Ole Solheim, PhD', 'role': 'CONTACT', 'email': 'ole.solheim@ntnu.no', 'phone': '+4772575256'}], 'overallOfficials': [{'name': 'Ole Solheim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}