[{"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":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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","validation-of-icg-99mtc-nanoscan-as-hybrid-tracer-for-sentinel-node-biopsy-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":61,"type":62},29,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68,69,70],"Penile Cancer","Melanoma","Oral Cancer",[72,73,74,75,76],"Fluorescence","Radioactivity","Indocyanine green","Clinical node negative patients","Surgical staging","2024-10-29",{"date":79,"type":80},"2024-10-30","ACTUAL",{"date":82,"type":80},"2023-04-01",{"date":84,"type":62},"2025-08",{"name":5,"class":6},1]