Superparamagnetic Iron Oxide (SPIO) vs Technetium for Sentinel Lymph Node Biopsy in Melanoma: Phase III Randomized Multi-center Non-Inferiority Trial (MagMen-II)
Summary
A randomized, international Phase III multi-center non-inferiority trial (NCT07552597, registered April 27, 2026) assessing Magtrace (superparamagnetic iron oxide, SPIO) versus the standard Technetium-99m plus Blue Dye (Tc99/BD) tracer method for sentinel lymph node identification in patients with cutaneous melanoma undergoing sentinel lymph node biopsy. The trial will enroll participants randomized 1:1 to either approach, with all participants undergoing both tracer methods in sequence along with pre-surgical lymphoscintigraphy and MRI imaging of sentinel lymph node basins.
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What changed
A new randomized Phase III clinical trial (NCT07552597, MagMen-II) was registered on ClinicalTrials.gov on April 27, 2026, evaluating the safety and efficacy of Magtrace (superparamagnetic iron oxide, SPIO) in identifying sentinel lymph nodes during biopsy procedures for patients with cutaneous melanoma. The trial employs a non-inferiority design with 1:1 randomization between two arms: standard Tc99/Blue Dye with gamma-probe first followed by Magtrace with magnetic probe, versus Magtrace first followed by Tc99/Blue Dye. All participants receive both tracer methods in sequence and undergo pre-surgical lymphoscintigraphy and MRI imaging.
For clinical investigators and oncology researchers, this trial registration signals a multi-center comparative evaluation of an emerging magnetic tracer technology against the current standard of care (Tc99/BD) in melanoma staging. Sponsors and clinical sites planning melanoma research programs should monitor trial outcomes as positive non-inferiority results could support broader adoption of SPIO-based sentinel lymph node localization, potentially reducing dependency on radioactive tracer protocols in eligible patient populations.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
Phase 3 NCT07552597 Kind: PHASE3 Apr 27, 2026
Abstract
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)
Interventions: Superparamagnetic Iron Oxide, Technetium (99mTc)
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