Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-25 @ 8:14 PM
Study NCT ID:
NCT03915392
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion Weighted MRI Accuracy in Cholesteatoma Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002781', 'term': 'Cholesteatoma'}], 'ancestors': [{'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI imaging study to locate cholesteatoma.', 'timeFrame': 'The period from January 1st, 2010 to Dcember 31, 2017 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffusion weighted MRI', 'Cholesteatoma', 'Localization'], 'conditions': ['Cholesteatoma']}, 'descriptionModule': {'briefSummary': 'Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent cholesteatoma surgery between January 1, 2010 and December 31, 2017', 'healthyVolunteers': False, 'eligibilityCriteria': "inclusion criteria\n\n* Age: from 1 month and up\n* Sex: man / woman\n* Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:\n\n * Code of the Common Classification of Medical Acts (CCAM)\n\n * Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002)\n * Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006)\n * Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005)\n * Tympanoplasty in closed technique with posterior tympanotomy (CBMD001)\n * Secondary tympanoplasty in closed technique (CBMD002)\n * Diagnostic code of the International Classification of Diseases (ICD10)\n\n * Cholesteatoma of the middle ear (H71)\n* Diagnosis of macroscopic and / or pathological cholesteatoma.\n* Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).\n* Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.\n\nCholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects.\n\nCriteria of non-inclusion\n\n* Refusal of the patient to participate in the study\n* Absence of data concerning the diagnosis and / or localization of cholesteatoma on the operative record\n* Subject under the protection of justice\n* Subject under guardianship or curatorship\n* Pregnancy (woman of childbearing age)\n* Breastfeeding"}, 'identificationModule': {'nctId': 'NCT03915392', 'acronym': 'CHOLEMRI', 'briefTitle': 'Diffusion Weighted MRI Accuracy in Cholesteatoma Localization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Diffusion Weighted MRI Accuracy in Cholesteatoma Localization', 'orgStudyIdInfo': {'id': '7122'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne CHARPIOT, MD, PhD', 'role': 'CONTACT', 'email': 'anne.charpiot@chru-strasbourg.fr', 'phone': '33 3 88 12 76 49'}, {'name': 'Antoine MERANGER, MD', 'role': 'CONTACT', 'email': 'antoine.meranger@chru-strasbourg.fr', 'phone': '33 3 88 12 76 49'}, {'name': 'Anne CHARPIOT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antoine MERANGER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francis VEILLON, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service D'Orl Et de Chirurgie Cervico-Faciale", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne CHARPIOT, MD, PhD', 'role': 'CONTACT', 'email': 'anne.charpiot@chru-strasbourg.fr', 'phone': '33 3 88 12 76 49'}, {'name': 'Antoine MERANGER, MD', 'role': 'CONTACT', 'email': 'antoine.meranger@chru-strasbourg.fr', 'phone': '33 3 88 12 76 49'}], 'overallOfficials': [{'name': 'Anne CHARPIOT, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}