Overview
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.
Description
The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.
Eligibility
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;