Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patient who will undergo a sentinel node procedure in routine care. * Patients \> 18 years; * Patients presenting with: * a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities; * OR patients presenting with a primary oral cavity malignancy T1-2N0 * OR patients with primary penile cancer * Patients with clinical N0 stage; * Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion; * Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting Exclusion Criteria: * Patients with known allergy to patent blue dye or nanocolloid; * Patients who are pregnant or breast-feeding mothers; * History of hypersensitivity reactions to products containing human serum albumin; * History of iodine allergy * Hyperthyroid or thyroidal adenoma * Kidney insufficiency * Incapacity or unwillingness of participant to give written informed consent;