Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06712303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Multi-detector CT and MRI in Diagnosis of Congenital Inner Ear Anomalies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}], 'ancestors': [{'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inner ear anomalies detection by CT and MRI', 'timeFrame': 'Baseline', 'description': 'accurate and early diagnosis of patsuffer from suffer from sensory neural hearing loss (SNHL)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Ct', 'Ear disease'], 'conditions': ['Ear Disease, Inner']}, 'descriptionModule': {'briefSummary': 'Evaluation of combined value of Multi-detector computed tomography (MDCT) and Magnetic resonance imaging (MRI) in the diagnosis of congenital abnormalities of the inner ear and internal auditory canal in patients with congenital hearing loss and preoperative evaluation of cochlear implant candidates.', 'detailedDescription': 'Introduction:\n\nInner ear malformation (IEM) with associated sensoryneural hearing loss (SNHL) is a major cause of childhood disability.\n\nThe embryology of the inner ear must be known as many of the inner ear malformations present as a result of the arrest during the various stages of embryology.\n\nCongenital malformations of the inner ear may be considered in two broad categories:\n\n1. malformations with pathologic changes that involve only the membranous labyrinth.\n2. malformations that involve both the osseous and the membranous labyrinth.\n\nCongenital sensorineural hearing loss arises as a result of abnormalities in the inner ear, the vestibulocochlear nerve, or the processing centres of the brain. The abnormality may have a genetic cause or be a sequel of infection or injury at birth; in some cases, no cause is identified.\n\nOne of the paths in the investigation of congenital sensorineural hearing loss (CSNHL) is to try to characterize its aetiology through the inner ear evaluation using high resolution computer tomography (CT) scans. With minor malformation, it is not always possible for a simple visual inspection to recognize if the structure in the inner ear is normal or not.\n\nBoth CT and MR can be used to look at inner ear malformations but often both techniques are complementary. CT is preferred when associated middle or external ear malformations must be excluded. Magnetic resonance is preferred when subtle changes in the membranous labyrinth or abnormalities of the nerves in the internal auditory canal must be visualised Moreover, some changes inside the membranous labyrinth can only be seen on sub-millimetric heavily T2-weighted MR images.\n\nOnly MR can demonstrate the abnormal course, hypoplasia or aplasia of the vestibulocochlear nerve (or one of is three branches) and facial nerve.\n\nHRCT and MRI temporal bone are complementary to each other in evaluating children for cochlear implantation as HRCT is excellent for demonstrating bony details but, lack in providing details of inner ear neural structures and MRI is better than CT in demonstrating vestibulocochlear nerves.\n\nCombined HRCT and MRI studies are mandatory for evaluation of inner ear, the radiologist must be familiar with imaging findings that absolutely contraindicate implantation (Cochlear aplasia, cochlear nerve aplasia and labyrinthine aplasia), and with those that relatively contraindicate implantation (labyrinthitis ossificans, other inner ear dysplasia) and with other findings that could significantly alter or complicate surgery (hypo plastic mastoid process, facial nerve dehiscence, oto-mastoiditis)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any age group come for cochlear implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patient of inner ear anomalies\n\nExclusion Criteria:\n\n* studied groups ,mri'}, 'identificationModule': {'nctId': 'NCT06712303', 'briefTitle': 'Role of Multi-detector CT and MRI in Diagnosis of Congenital Inner Ear Anomalies', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Multi-detector CT and MRI in Diagnosis of Congenital Inner Ear Anomalies', 'orgStudyIdInfo': {'id': 'CT,MRI in inner ear anomalies'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI ,ct', 'type': 'DEVICE', 'description': 'Every patient will be subjected to\n\n1\\. MSCT examination: All patients will undergo MSCT (Siemens somatom 32 slice ,16 slice ,GE bright speed 16 slice ) Non contrast high-resolution CT of the temporal bone with the following parameters:{ 0.75-mm collimation, 130 kvp, 20 mA, topogram length 265}. Patients will be scanned in the supine position with craniocaudal direction. Scanning will be parallel to the orbito-meatal line from the lower margin of the external auditory meatus and extended upward to the arcuate eminence of the superior semicircular canal, as seen on the lateral topogram. Followed by image reconstruction in both the axial and coronal planes to evaluate the inner ear and its malformations, The initial data sets will be reconstructed at 0.6 mm slice thickness. The raw axial image data set can be reconstructed with a section thickness of as little as 0.3 mm to obtain high-quality coronal reformatted images. A 512 × 512 matrix is used, and all the images are reviewed wit'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah K Fahmi', 'role': 'CONTACT', 'email': 'Khaledsarah155@gmail.com', 'phone': '+201554577818', 'phoneExt': '+01017507865'}], 'overallOfficials': [{'name': 'Yasser Y. Mohamed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor doctor'}, {'name': 'Hossam E. Mohamed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Khaled Fahmi', 'investigatorAffiliation': 'Assiut University'}}}}