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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07552597

Acronym

MagMen-II

Enrollment

254

Registered

2026-04-27

Start date

2026-05-04

Completion date

2029-12-31

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin Cancer)

Keywords

melanoma, sentinel node biopsy, magnetic tracer, Magtrace

Brief summary

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.

Interventions

DEVICESuperparamagnetic Iron Oxide

magnetic tracer for melanoma

DRUGTechnetium (99mTc)

Radioactive tracer

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Masking description

Radiologist are blinded to the result of the sentinel node biopsy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
SLN detection	Within 6 weeks from surgery (10 weeks from enrollment)	The proportion (%) of persons with at least one histologically verified SLN per tracer method

Contacts

CONTACTEllen Krabbe, MD, PhD-candidate

ellen.svensson@vgregion.se+ 46 (0) 31-342 62 65

CONTACTFredrik Wärnberg, MD, PhD

fredrik.warnberg@vgregion.se+46 70 6146251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026