Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Superparamagnetic Iron Oxide, Technetium (99mTc).
- Who it may be relevant to
- Registry conditions: Melanoma (Skin Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Superparamagnetic Iron Oxide
magnetic tracer for melanoma - Drug Technetium (99mTc)
Radioactive tracer
Primary outcome measures
- SLN detection [Time frame: Within 6 weeks from surgery (10 weeks from enrollment)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Pregnant or breast-feeding
- Inability to undergo any of the study procedures
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07552597 · SUGBG2024004 · CIV-ID: 24-12-050341