[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608619":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":155,"collaborators":159,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":178,"maxAge":26,"enrollmentInfo":179,"targetDuration":26,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":26,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.",[13],"Other: Standard Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention","EXPERIMENTAL","In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor\u002Fhost interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.",[19],"Diagnostic Test: Ultrasound imaging",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Ultrasound imaging","Ultrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In the ex-vivo phase the resected tumor will undergo ultrasound by using a motorized mechanical arm designed to hold an ultrasound transducer. This ensures standardized and reproducible scans. The purpose of the ex-vivo scan is to measure the surgical margins at the operating theatre and allow for an immediate re-resection of necessary. Surgeons in the intervention group will also have the possibility of taking biopsies for frozen section analyses.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Treatment","Standard surgical treatment of oral cancer",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Daniel J Lauritzen, MD","CONTACT","+4541817574","daniel.julius.lauritzen@regionh.dk",[38,60,75,92,107,123,139],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Stanford Otolaryngology - Head & Neck Surgery Department","NOT_YET_RECRUITING","Stanford","California","94305","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-122.16608,37.42411,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Lisa A Orloff, MD, FACS, FACE","(650) 736-1680","lorloff@stanford.edu",{"name":58,"role":34,"phone":26,"phoneExt":26,"email":59},"Michelle Chen, Ass. Prof.","michelle.chen@stanford.edu",{"facility":61,"status":40,"city":62,"state":63,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Emory University Hospital","Atlanta","Georgia","30322",{"type":47,"coordinates":66},[67,68],-84.38798,33.749,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":73,"phoneExt":26,"email":74},"Merry E Sebelik","404-778-3381","merry.sebelik@emory.edu",{"facility":76,"status":77,"city":78,"state":26,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Department of Otorhinolaryngology Head and Neck Surgery","RECRUITING","Aarhus","8200","Denmark","DK",{"type":47,"coordinates":83},[84,85],10.21076,56.15674,{"lat":85,"lon":84},[88],{"name":89,"role":34,"phone":90,"phoneExt":26,"email":91},"Thomas Kjærgaard, MD, PhD","+4578450000","thokjaer@rm.dk",{"facility":93,"status":77,"city":94,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet","Copenhagen",{"type":47,"coordinates":96},[97,98],12.56553,55.67594,{"lat":98,"lon":97},[101,105],{"name":102,"role":34,"phone":103,"phoneExt":26,"email":104},"Tobias Todsen, MD, PhD, Ass. Prof.","+4535453545","tobias.todsen@regionh.dk",{"name":33,"role":106,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":108,"status":40,"city":109,"state":26,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Istituto Nazionale Tumori of Milan","Milan","20133","Italy","IT",{"type":47,"coordinates":114},[115,116],9.18951,45.46427,{"lat":116,"lon":115},[119],{"name":120,"role":34,"phone":121,"phoneExt":26,"email":122},"Alberto Deganello","+39 02 23901","adeganello@hotmail.com",{"facility":124,"status":40,"city":125,"state":26,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Groote Schuur","Cape Town","7935","South Africa","ZA",{"type":47,"coordinates":130},[131,132],18.42322,-33.92584,{"lat":132,"lon":131},[135],{"name":136,"role":34,"phone":137,"phoneExt":26,"email":138},"Matthew White","+27 21 404 9111","matthewwhite86@yahoo.com",{"facility":140,"status":77,"city":141,"state":26,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Karolinska Institute","Stockholm","17177","Sweden","SE",{"type":47,"coordinates":146},[147,148],18.06871,59.32938,{"lat":148,"lon":147},[151],{"name":152,"role":34,"phone":153,"phoneExt":26,"email":154},"Mathias von Beckerath","+46 8 524 800 00","mathias@beckerath.se",{"type":156,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Tobias Todsen","MD, PhD, Ass. Prof.",[160,162,164,166,168],{"name":161,"class":6},"Karolinska Institutet",{"name":163,"class":6},"National Cancer Institute, Milan",{"name":165,"class":6},"Aarhus University Hospital",{"name":167,"class":6},"Odense University Hospital",{"name":169,"class":6},"Aalborg University Hospital","100608619","surgeon-performed-ultrasound-for-real-time-guidance-in-oral-cancer-surgeries---a-multicenter-randomized-controlled-trial-100608619",false,"NCT07203911","Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial","SURGIO","Inclusion criteria\n\n• Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.\n\nExclusion criteria\n\n* Age \\\u003C 18 years.\n* Oral cancer with suspected bone involvement.\n* Unable to understand verbal or written information.\n* Prior radiotherapy treatment of oral cavity cancer.\n* Tumor not visible on ultrasound.","ALL","18 Years",{"count":180,"type":181},150,"ESTIMATED","INTERVENTIONAL",[184],"NA","The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer.\n\nParticipants will be randomized to either the control or intervention group:\n\n* Control group will receive standard treatment for oral cancer.\n* Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively.\n\nOutcomes:\n\n* Number of free surgical margins between control and intervention group.\n* Intraoperative surgeon assessed surgical margins compared to final histology report.\n* Dysphagia and quality of life questionnaires.\n* Recurrence rates.\n* Mortality rates.\n\nAll participant will be followed-up at 3 months and 12 months with:\n\n* MDADI dysphagia questionnaire\n* EORTC head and neck cancer quality of life questionnaire\n* Follow-up on recurrrence and mortality.",[187,188,189],"Tongue Cancer","Oral Cancer","Squamous Cell Carcinoma of the Oral Cavity or Oropharynx","2026-05-10",{"date":192,"type":193},"2026-05-13","ACTUAL",{"date":195,"type":193},"2025-09-15",{"date":197,"type":181},"2031-08",{"name":157,"class":6},7]