head/neck/trunk melanoma oral malignancies penile carcinoma
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion 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, upper part of the trunk, and extremities; * Patients presenting with a primary oral cavity malignancyT1-2N0; * 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
Exclusion criteria: * Patients with known allergy to patent blue dye; * 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To show concordance between ICG-99mTc-Nanoscan and 99mTc-Nanoscan SLN visualized on preoperative lymphoscintigraphy and SPECT/CT imaging, where concordance is defined as at most 1 sentinel node detected by one tracer being missed by the other tracer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 2. Concordance between intraoperative fluorescence and radioactive findings using: • Number and intensity of the fluorescent nodes at time of excision; • Number and radioactive signal intensity of the radioactive nodes at time of excision; | — |
Countries
Netherlands
Outcome results
None listed