Melanoma (Skin Cancer)Phase 3MagMen-IINCT07552597
Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma: MagMen-II
A Phase 3 study testing Superparamagnetic Iron Oxide and Technetium (99mTc) in people with Melanoma (Skin Cancer), run by Vastra Gotaland Region.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Superparamagnetic Iron Oxide and Technetium (99mTc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breast-feeding
- Inability to undergo any of the study procedures
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
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)
- Being tested
- Superparamagnetic Iron Oxide, Technetium (99mTc)
- Keywords
- melanoma, sentinel node biopsy, magnetic tracer, Magtrace
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superparamagnetic Iron OxideDevice
magnetic tracer for melanoma
Technetium (99mTc)Drug
Radioactive tracer
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Active comparator | 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®. Receives: Device: Superparamagnetic Iron Oxide |
| Control | Active comparator | 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. Receives: Drug: Technetium (99mTc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLN detection
The proportion (%) of persons with at least one histologically verified SLN per tracer method
Measured: Within 6 weeks from surgery (10 weeks from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552597
- Sponsor's protocol ID
- SUGBG2024004
- Other IDs
- CIV-ID: 24-12-050341
- Acronym
- MagMen-II
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II
- ClinicalTrials.gov ID
- NCT07552597
- Acronym / sponsor ID
- MagMen-II / SUGBG2024004
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- melanoma, sentinel node biopsy, magnetic tracer, Magtrace
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Active comparator | Device: Superparamagnetic Iron OxideParticipants 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®. |
| Control | Active comparator | Drug: Technetium (99mTc)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding
- Inability to undergo any of the study procedures
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superparamagnetic Iron Oxidemagnetic tracer for melanoma | Device | Experimental arm |
| Technetium (99mTc)Radioactive tracer | Drug | Control |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Superparamagnetic Iron Oxide and Technetium (99mTc) in people with Melanoma (Skin Cancer), run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Krabbe, MD, PhD-candidate (+ 46 (0) 31-342 62 65, ellen.svensson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLN detection (time frame: Within 6 weeks from surgery (10 weeks from enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.