Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II

Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II

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.

Inclusion criteria:

1. Male or female aged above 18 years
2. Signed and dated written informed consent before the start of specific protocol procedures
3. Histologically confirmed melanoma planned for wide local excision and sentinel lymph node biopsy

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Inability to undergo any of the study procedures
3. Iron overload disease
4. Known hypersensitivity to iron or dextran compounds