Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT04417868
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-06-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evolution of Cochleovestibular Schwannomas
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': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA', 'timeFrame': '1 hour after the realization of the MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schwannoma', 'cochleovestibular schwannomas', 'cochleovestibular', 'intra labyrinthine schwannoma'], 'conditions': ['Schwannoma']}, 'descriptionModule': {'briefSummary': 'Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.\n\nThe secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg\n* patients consenting to participate\n\nExclusion Criteria:\n\n* intra-labyrinthical extension\n* treatment before the 3 MRIs\n* no injection of gadolinium\n* atypical diagnosis'}, 'identificationModule': {'nctId': 'NCT04417868', 'briefTitle': 'Evolution of Cochleovestibular Schwannomas', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evolution of Cochleovestibular Schwannomas in the Internal Auditory Canal by Volume Measering With aTeslas MRI 3', 'orgStudyIdInfo': {'id': '7560'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Srtrasbourg', 'state': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francis VEILLON, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien UTTNER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Imagerie 1'}], 'centralContacts': [{'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}