Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 254
- Primary Endpoint
- SLN detection
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Radiologist are blinded to the result of the sentinel node biopsy
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental arm
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®.
Intervention: Superparamagnetic Iron Oxide (Device)
Control
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.
Intervention: Technetium (99mTc) (Drug)
Outcomes
Primary Outcomes
SLN detection
Time Frame: Within 6 weeks from surgery (10 weeks from enrollment)
The proportion (%) of persons with at least one histologically verified SLN per tracer method
Secondary Outcomes
No secondary outcomes reported