Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Superparamagnetic Iron Oxide | Device | — | UNRESOLVED |
| Technetium (99mTc) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental arm
- description
- 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®.
- interventionNames
- Device: Superparamagnetic Iron Oxide
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- 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.
- interventionNames
- Drug: Technetium (99mTc)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available