NCT07552597
Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma: MagMen-II
Not Yet Recruiting · Phase 3 · Vastra Gotaland Region · registry updated 2026-09-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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
Exclusion
- Pregnant or breast-feeding
- Inability to undergo any of the study procedures
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds