[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390931":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":20,"responsibleParty":37,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":7,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":7,"enrollmentInfo":52,"targetDuration":7,"studyType":55,"phases":7,"briefSummary":56,"conditions":57,"keywords":7,"overallStatus":23,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Stephen EJ Connor, MRCP FRCR","PRINCIPAL_INVESTIGATOR",[13,17],{"name":10,"role":14,"phone":15,"phoneExt":7,"email":16},"CONTACT","07816882304","steve.connor@nhs.net",{"name":18,"role":14,"phone":7,"phoneExt":7,"email":19},"Irumee Pai, FRCS","irumee.pai@gstt.nhs.uk",[21],{"facility":22,"status":23,"city":24,"state":7,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"King's College London","RECRUITING","London","SW1P 4AL","United Kingdom","UK",{"type":29,"coordinates":30},"Point",[31,32],-0.12574,51.50853,{"lat":32,"lon":31},[35],{"name":36,"role":14,"phone":15,"phoneExt":7,"email":7},"Steve Connor",{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[40,41],{"name":22,"class":6},{"name":42,"class":6},"Guy's and St Thomas' NHS Foundation Trust","100390931","imaging-of-endolymphatic-hydrops-at-7t-mri-100390931",false,"NCT04370366","Imaging of Endolymphatic Hydrops at 7T MRI","Imaging Endolymphatic Hydrops at 7T MRI: Validation of Internal Inner Ear Structures on T2w Imaging as Markers of Endolymphatic Hydrops and a Comparison of Diagnostic Outcomes With 3T MRI","Inclusion Criteria\n\n* Male or female, 18 years of age or older\n* The capacity to understand the patient information sheet and the ability to provide written informed consent\n* Unilateral audio-vestibular symptoms which satisfy 2015 Barany criteria for unilateral Meniere's Disease of less than 5 years duration\n* Would be offered clinical MRI scanning for confirmation of a Meniere's disease diagnosis as part of standard of care\n\nExclusion Criteria:\n\n* Standard contraindications to 7T MRI\n* Known allergy to Gadolinium contrast\n* Calculated GFR \\\u003C 30 mls\u002Fmin\n* Previous temporal bone surgery or trauma\n* Other known temporal bone pathology\n* Requirement for early post gadolinium sequences (e.g. autoimmune inner disease as a differential diagnosis)","ALL","18 Years",{"count":53,"type":54},16,"ESTIMATED","OBSERVATIONAL","Imaging endolymphatic hydrops with 7T Sodium Imaging and 1.5 T gadolinium enhanced imaging: a comparison of diagnostic outcomes with 3T MRI\n\nDuration of study 24 months\n\nStudy design Prospective cohort study\n\nNumber of patients 16 patients\n\n1. To evaluate whether imaging both 1.5T and 3T have an equivalent performance in terms of diagnosing MD ears with delayed post gadolinium enhanced MRI (applying quantitative and semi-quantitative analysis)\n2. To compare the diagnostic performance of Sodium Imaging at 7T (applying semi-quantitative analysis) with that of delayed post gadolinium enhanced 3T MRI in distinguishing symptomatic from asymptomatic Meniere's Disease (MD) ears.",[58],"Meniere Disease","2024-03-05",{"date":61,"type":62},"2024-03-06","ACTUAL",{"date":64,"type":62},"2023-07-01",{"date":66,"type":54},"2026-07-01",{"name":5,"class":6},1]