[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632807":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":31,"responsibleParty":55,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Secondary lymph node detection","EXPERIMENTAL",null,[13,14],"Drug: Patent blue V dye injection","Drug: Indocyanine green dye injection",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Patent blue V dye injection","Patent Blue V dye is injected around the primary tumor.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Indocyanine green dye injection","Indocyanine green dye is injected inside the metastatic lymph node(s).",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Christian Simon, Professor","CONTACT","+41 21 314 05 39","christian.simon@chuv.ch",[32,45],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"Centre Hospitalier Universitaire Vaudois (CHUV)","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":40,"coordinates":41},"Point",[42,43],6.63282,46.516,{"lat":43,"lon":42},{"facility":46,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"CHUV",{"type":40,"coordinates":48},[42,43],{"lat":43,"lon":42},[51],{"name":52,"role":28,"phone":53,"phoneExt":11,"email":54},"Virginie Zimmer","+41 79 556 69 47","virginie.zimmer@chuv.ch",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Christian Simon","Professor","100632807","phase-2-prospective-clinical-study-to-identify-secondary-sentinel-lymph-nodes-in-patients-with-n1n2b-oral-cavity-or-hn-skin-cancers-using-patent-blue-v-and-indocyanine-green-dyes-100632807",false,"NCT07518485","Prospective Clinical Study to Identify Secondary Sentinel Lymph Nodes in Patients With N1\u002FN2b Oral Cavity or H&N Skin Cancers Using Patent Blue V and Indocyanine Green Dyes","Prospective Clinical Study to Identify Secondary Sentinel Lymph Nodes in Patients With N1\u002FN2b Oral Cavity or H&N Skin Cancers Using Patent Blue V and Indocyanine Green Dyes (preReDSeL Study)","preReDSeL","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Operable SCC located in the oral cavity or the skin of the H\\&N region, with one or two LNM\n3. Primary disease\n4. ECOG performance status 0-2\n5. Signed study informed consent form for participation\n\nExclusion Criteria:\n\n1. Non-operable tumors or contraindication to surgery\n2. Previously treated head and neck cancer. Note: neoadjuvant treatment is not an exclusion criterion\n3. Known hypersensitivity\u002Fallergy to triphenylmethane-based (Blue) dyes or to any of their components\n4. Known hypersensitivity\u002Fallergy to indocyanine green or sodium iodide or iodine\n5. Patients with known hyperthyroidism, thyroid autonomy (e.g., autonomous adenoma), or any thyroid disorder that may lead to increased iodine uptake\n6. Patients with severe renal impairment (e.g., estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n7. Patients receiving beta-blocker therapy, as these medications may mask or reduce the response to anaphylactic reactions induced by dye injection\n8. Pregnancy and\u002For ongoing breastfeeding\n9. Any reason that would interfere with the patient's well-being and treatment as assessed by the investigator","ALL","18 Years",{"count":70,"type":71},20,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Head and neck (H\\&N) cancer has a poor prognosis and high morbidity with \\~50% survival and frequent treatment resistance. Most deaths result from local or loco-regional progression rather than distant metastasis. Lymphatic spread to regional lymph nodes (RLNs), especially with extra-nodal extension (ENE), is a key predictor of poor outcomes. Current imaging techniques often miss micrometastases, leading to extensive but sometimes unnecessary neck treatments. Sentinel lymph node biopsy (SLNB) offers a precise method to detect early spread but is not yet widely adopted. Identifying second-echelon sentinel nodes-those receiving drainage from primary or first-tier nodes-may further refine treatment. The preReDSeL study evaluates the use of dyes (indocyanine green and Patent Blue V) for detecting these nodes. Success could reduce morbidity and guide tailored surgical\u002Fradiation therapy. The follow-up ReDSeL study will assess the clinical value of these findings.",[77,78],"N1\u002FN2b Oral Cavity Cancer","Head and Neck Skin Cancer",[80,81,82,83,84],"oral cavity cancer","head and neck skin cancer","patent blue V","indocyanine green","secondary sentinel lymph nodes","NOT_YET_RECRUITING","2026-04-07",{"date":88,"type":89},"2026-04-08","ACTUAL",{"date":91,"type":71},"2026-04",{"date":93,"type":71},"2027-04",{"name":5,"class":6},2]