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

April 20, 2026 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental arm
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
magnetic tracer for melanoma
Active Comparator: Control
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)
Radioactive tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 6 weeks from surgery (10 weeks from enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 4, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUGBG2024004
  • CIV-ID: 24-12-050341 (Other Identifier: Swedish Medical Products Agency)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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