[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518358":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":30,"collaborators":34,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":7,"enrollmentInfo":47,"targetDuration":50,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Ligita P Frøding","CONTACT","+4522722972","ligita.paskeviciute.froeding@regionh.dk",[15],{"facility":16,"status":17,"city":18,"state":7,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"Copenhagen University Hospital","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":23,"coordinates":24},"Point",[25,26],12.56553,55.67594,{"lat":26,"lon":25},[29],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Ligita Paskeviciute Froding","Principal Investigator",[35],{"name":36,"class":6},"Aarhus University Hospital","100518358","optical-guided-sentinel-node-biopsy-for-staging-of-vulvar-cancer-i-100518358",false,"NCT06029504","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer","SENTIVUC","Inclusion Criteria:\n\n* Patients with primary vulva cancer, FIGO stage IB (tumor \\\u003C 4 cm)\n* Patients with unifocal recurrence in the vulva (tumor \\\u003C 4 cm) located on the side where the patient is surgically naïve in the groin\n\nExclusion Criteria:\n\n* Prior irradiation of the vulva or groins\n* Prior SNB or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)","FEMALE","18 Years",{"count":48,"type":49},115,"ESTIMATED","1 Year","OBSERVATIONAL","The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \\\u003C 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \\\u003C 4 cm.",[54,55],"Vulvar Cancer","Sentinel Lymph Node","2023-11-29",{"date":58,"type":59},"2023-12-06","ACTUAL",{"date":61,"type":59},"2023-01-01",{"date":63,"type":49},"2027-12-31",{"name":5,"class":6},1]