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

NCT07552597 | Not Yet Recruiting Phase 3

• 2 other identifiers: SUGBG2024004CIV-ID: 24-12-050341
• Study Type: interventional
• Target: 254
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma (Skin Cancer)

Keywords

melanoma; sentinel node biopsy; magnetic tracer; Magtrace

Outcome Measures

Primary Outcomes (1)

• SLN detection

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

  Within 6 weeks from surgery (10 weeks from enrollment)

Study Arms (2)

Experimental arm

ACTIVE COMPARATOR

Participants will be injected with both tracer methods (Tc99/BD and Magtrace®) and will undergo both a lymphoscintigraphy and an MRI of the SLN basins. The participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99 and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99. In the experimental arm patients will start with Magtrace®.

Device: Superparamagnetic Iron Oxide

Control

ACTIVE COMPARATOR

Participants will be injected with both tracer methods (Tc99/BD and Magtrace®) and will undergo both a lymphoscintigraphy and an MRI of the SLN basins. The participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99 and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99. In the control arm patients will start with Technetium-99 and Blue Dye.

Drug: Technetium (99mTc)

Interventions

Superparamagnetic Iron Oxide DEVICE

magnetic tracer for melanoma

Experimental arm

Technetium (99mTc) DRUG

Radioactive tracer

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Melanoma

Interventions

Technetium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Central Study Contacts

Ellen Krabbe, MD, PhD-candidate

CONTACT

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

Fredrik Wärnberg, MD, PhD

CONTACT

+46 70 6146251; fredrik.warnberg@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiologist are blinded to the result of the sentinel node biopsy
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04