A randomized, international, phase III, multi-center, non- inferiority trial assessing the safety and efficacy of MagtraceĀ® (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 MagtraceĀ®). 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 MagtraceĀ® and magnetic probe, or SLNB using MagtraceĀ® followed by Tc99/BD. Randomization will be stratified by study site using permuted variable block sizes.
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SLN detection
Timeframe: Within 6 weeks from surgery (10 weeks from enrollment)
Ellen Krabbe, MD, PhD-candidate