Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT03580850
Status:
UNKNOWN
Last Update Posted:
2018-07-13
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Scan and Intra-labyrinthine Schwannoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009442', 'term': 'Neurilemmoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA alone', 'timeFrame': '1 hour after the realization of the MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intra labyrinthine schwannoma', 'schwannoma', 'magnetic resonance imaging (MRI)', 'gadolinium', 'T2 weighted gradient echo'], 'conditions': ['Schwannoma']}, 'descriptionModule': {'briefSummary': 'Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient having intra-labyrinthine schwannoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Have intra-labyrinthine schwannoma\n* Have benefited from an MRI with gadolinium injection on the MRI 3T with interpretable sequences of good quality\n* Subject giving their consent for their participation\n* Subjects who benefited, between 2009 and 2016, from an MRI of the external auditory canals, with gadolinous product injection and on the 3 Tesla MRI, in which a diagnosis of intra labyrinthine schwannoma was made\n\nExclusion Criteria:\n\n\\- Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03580850', 'briefTitle': 'MRI Scan and Intra-labyrinthine Schwannoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS', 'orgStudyIdInfo': {'id': '6809'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention in this restrospective study', 'type': 'OTHER', 'description': 'This study is an obervational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Francis VEILLON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne KAROL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Imagerie 1', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'email': 'Francis.veillon@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}], 'overallOfficials': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}