Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04339205
Status:
UNKNOWN
Last Update Posted:
2020-07-01
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diffusion Imaging in Acute Auto-immune Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI characterization, especially in Diffusion-weighted magnetic resonance imaging (DWI-MRI), of auto-immune encephalitis at presentation.', 'timeFrame': 'at following-up until 24 months', 'description': 'The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed.\n\nAt each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium.\n\nThe radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain.\n\nWe will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI'], 'conditions': ['Auto-immune Encephalitis']}, 'descriptionModule': {'briefSummary': 'The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.\n\nIndeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with auto-immune encephalitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Auto-immune encephalitis proved by biological results (blood and/or CSF sample)\n\nExclusion Criteria:\n\n* No MRI available'}, 'identificationModule': {'nctId': 'NCT04339205', 'briefTitle': 'Diffusion Imaging in Acute Auto-immune Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Diffusion Imaging in Acute Auto-immune Encephalitis : a Cohort of 80 Patients', 'orgStudyIdInfo': {'id': 'Imaging study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.', 'type': 'OTHER', 'description': 'The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed.\n\nAt each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium.\n\nThe radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain.\n\nWe will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François COTTON, PhD', 'role': 'CONTACT'}, {'name': 'Géraldine PICARD', 'role': 'CONTACT', 'email': 'geraldine.picard@chu-lyon.fr', 'phone': '04 72 35 58 42'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'François cotton, phd', 'role': 'CONTACT', 'email': 'francois.cotton@chu-lyon.fr', 'phone': '04 78 56 91 00'}, {'name': 'Géraldine PICARD', 'role': 'CONTACT', 'email': 'geraldine.picard@chu-lyon.fr', 'phone': '04 72 35 58 42'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}