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

Starting soon · Phase 3

Conditions studied: Melanoma (Skin Cancer)

In brief

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.

Key facts

Study ID

NCT07552597

Run by

Vastra Gotaland Region

People needed

254

Starts

2026-05-04

Expected to finish

2029-12-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant or breast-feeding
• Inability to undergo any of the study procedures
• Iron overload disease
• Known hypersensitivity to iron or dextran compounds

Full record on ClinicalTrials.gov

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