NCT07552597Not yet recruitingPhase 3
Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma: MagMen-II
Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 254 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Melanoma
- NCT number
- NCT07552597
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 254
- From 1 Oct 2026 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
Other
- Pregnant or breast-feeding
- Inability to undergo any of the study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.