Clinical trial · Interventional
The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study.
Sentinel Node Localisation and Staging With Superparamagnetic Iron Oxide-enhanced MRI and Magtrace®/Sentimag® in Patients With Malignant Melanoma of the Extremities. The MAGMEN Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the use of superparamagnetic iron oxide (Magtrace®) as a tracer in sentinel node biopsy in malignant melanoma of the extremities, and to evaluate the possible role of Magtrace®-MRI for staging. Primary objective: • To evaluate if Magtrace®/Sentimag® can be used to identify SN in malignant melanoma with the same diagnostically reliability as the currently used method of Technetium 99m and Patent blue. Secondary objectives: • To evaluate if Magtrace®-MRI can predict sentinel node status in melanoma. This is a feasibility phase I, interventional single arm study. All patients included in the study will receive the same management. 20 patients will be included in the study. An enrollment time of 6-12 months is expected. Primary endpoint • To determine the detection rate of Magtrace®/Sentimag® in comparison to SNB using technetium and blue dye in patients with malignant melanoma of the extremities. Secondary endpoint • To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLN Biopsy with Magtrace®/Sentimag® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MAGMEN arm
- description
- Patients with melanoma of the extremities included in the protocol. SLNB will be performed with the addition of magtrace (SPIO) injection, 0.2 ml around previous scar. The patients will undergo MRI of the involved basin (Axilla-groin)and receive the SpIO injection the day before SLN biopsy. A separate SPIO MRI will be performed before the operation. All patients will receive all 3 methods for SLN identification as described in the protocol.
- interventionNames
- Device: SLN Biopsy with Magtrace®/Sentimag®
Primary outcomes (1)
- measure
- Identification of Sentinel node with Magtrace®/Sentimag®
- timeFrame
- 12 months
- description
- More than 95% success rate for identification of the Sentinel node with Magtrace®/Sentimag®
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: A patient meeting ALL of the following criteria is eligible for participation in the study 1. Male or female aged above 18 years. 2. Signed and dated written informed consent before the start of specific protocol procedures. 3. Histologically confirmed melanoma of the extremities that is candidate to wide local excision and sentinel node biopsy (SLNB). 4. ECOG performance status 0-2 Exclusion Criteria: A patient meeting ANY of the following criteria is not eligible for study participation: 1. Life expectancy of less than 6 months 2. Pregnant or breast-feeding. 3. Body Mass Index (BMI) \> 45 4. Pacemaker or metal implants 5. Claustrophobia 6. Clinically suspect lymph nodes metastasis on palpation 7. Iron overload disease 8. Known hypersensitivity to iron or dextran compounds 9. Inability to understand given information and give informed consent or undergo study procedures
References
Publications (0)
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