A randomized, international, phase III, multi-center, non- inferiority trial assessing the safety and efficacy of Magtrace® (superparamagnetic iron oxide, SPIO) in identification of lymph nodes in patients with cutaneous melanoma undergoing a sentinel lymph node biopsy (SLNB). Participants will be injected with both tracer methods Technetium (Tc99) plus Blue Dye (BD) and Magtrace®). They will undergo both a lymphoscintigraphy and a Magnetic Resonance Imaging (MRI) of the SLN basins. Before surgery, the participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99/BD and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99/BD. Randomization will be stratified by study site using permuted variable block sizes.
Male or female aged above 18 years
Signed and dated written informed consent before the start of specific protocol procedures
Histologically confirmed melanoma planned for wide local excision and sentinel lymph node biopsy
Pregnant or breast-feeding
Inability to undergo any of the study procedures
Iron overload disease
Known hypersensitivity to iron or dextran compounds
Crossover
Superparamagnetic Iron Oxide
Devicemagnetic tracer for melanoma
Technetium (99mTc)
DrugRadioactive tracer
SLN detection
The proportion (%) of persons with at least one histologically verified SLN per tracer method
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This trial is not recruiting at the moment. You can still explore other options:
