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Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma: MagMen-II

Study acronym: MagMen-II
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2029 → Dec 31, 2030
See other at-risk trials from Vastra Gotaland Region

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2029 to Dec 31, 2030
    • Start date: May 4, 2026 to Oct 1, 2026
    • Study title shortened, about 8 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Vastra Gotaland Region
139 trials monitored
See 11 trials at risk
Melanoma
1,092 trials monitored
See 60 trials at risk
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.
Trial Details
NCT Number NCT07552597
Lead Sponsor Vastra Gotaland Region
Conditions
(from sponsor)		 Melanoma (Skin Cancer)
Related terms Melanoma
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov