Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT03618251
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Volume Assessment of Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Automated volume assessment of acute stroke', 'timeFrame': '1 hour', 'description': 'Our objective is to compare several volumetric techniques (manual, semi-manual, automatic) based on the B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion.\n\nWe will also evaluate the correlation between the volumes obtained by the different techniques and the final volume of FLAIR infarction and diffusion in a subgroup of patients for whom a follow-up MRI is feasible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging']}, 'descriptionModule': {'briefSummary': 'Stroke is a common disease. It is increasingly managed in non-specialized centers.\n\nThe volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.\n\nThere is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.\n\nThe Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.\n\nManual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'we will include all adult patient with ischemic stroke which have MRI for stroke diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.\n\nNon inclusion criteria :\n\n* Pregnant or breastfeeding women\n* Patients with absolute contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT03618251', 'acronym': 'AVAAS', 'briefTitle': 'Automated Volume Assessment of Acute Stroke', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours', 'orgStudyIdInfo': {'id': 'FCD_2017_20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ischemic stroke', 'description': 'all patients with a suspicion of ischemic stroke', 'interventionNames': ['Diagnostic Test: specific MRI sequences']}], 'interventions': [{'name': 'specific MRI sequences', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion', 'armGroupLabels': ['ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation A De Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}