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.

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Key information

Conditions

Melanoma (Skin Cancer) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Superparamagnetic Iron Oxide

Device

magnetic tracer for melanoma

Technetium (99mTc)

Drug

Radioactive tracer

Primary outcomes

SLN detection

Time frame: Within 6 weeks from surgery (10 weeks from enrollment)

The proportion (%) of persons with at least one histologically verified SLN per tracer method

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Krabbe, MD, PhD-candidate

CONTACT

[email protected]

+ 46 (0) 31-342 62 65

Fredrik Wärnberg, MD, PhD

CONTACT

[email protected]

+46 70 6146251

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Acronym: MagMen-II

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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