[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567318":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":29,"responsibleParty":49,"collaborators":18,"id":51,"slug":18,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan","The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care.",[12],"Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Oscar Brouwer, Dr.","CONTACT","0205129111","o.brouwer@nki.nl",{"name":26,"role":22,"phone":27,"phoneExt":18,"email":28},"Daphne Rietbergen, Dr.","0715269111","d.d.d.rietbergen@lumc.nl",[30],{"facility":31,"status":32,"city":33,"state":18,"zip":18,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"NKI-AVL","RECRUITING","Amsterdam","Netherlands","NL",{"type":37,"coordinates":38},"Point",[39,40],4.88969,52.37403,{"lat":40,"lon":39},[43,46],{"name":44,"role":22,"phone":45,"phoneExt":18,"email":24},"Oscar Dr. O. Brouwer","+31205129111",{"name":47,"role":48,"phone":18,"phoneExt":18,"email":18},"Oscar Brouwer","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100567318",false,"NCT06666634","Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy","NANOSCAN","Inclusion Criteria:\n\n* Patient who will undergo a sentinel node procedure in routine care.\n* Patients \\> 18 years;\n* Patients presenting with:\n* a primary cutaneous melanoma of head\u002Fneck or upper part of the trunk or extremities;\n* OR patients presenting with a primary oral cavity malignancy T1-2N0\n* OR patients with primary penile cancer\n* Patients with clinical N0 stage;\n* Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;\n* Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting\n\nExclusion Criteria:\n\n* Patients with known allergy to patent blue dye or nanocolloid;\n* Patients who are pregnant or breast-feeding mothers;\n* History of hypersensitivity reactions to products containing human serum albumin;\n* History of iodine allergy\n* Hyperthyroid or thyroidal adenoma\n* Kidney insufficiency\n* Incapacity or unwillingness of participant to give written informed consent;","ALL","18 Years",{"count":60,"type":61},29,"ESTIMATED","INTERVENTIONAL",[64],"NA","99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.",[67,68,69],"Penile Cancer","Melanoma","Oral Cancer",[71,72,73,74,75],"Fluorescence","Radioactivity","Indocyanine green","Clinical node negative patients","Surgical staging","2024-10-29",{"date":78,"type":79},"2024-10-30","ACTUAL",{"date":81,"type":79},"2023-04-01",{"date":83,"type":61},"2025-08",{"name":5,"class":6},1]