Clinical trial · Observational
Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
NCT03449615CI-TRIAL-00031875IMINEMunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.
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 Stage | Melanoma | PROBABILISTIC | 0.70 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- SN detection
- timeFrame
- During surgery
- description
- Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria.
Secondary outcomes (1)
- measure
- SN agreement
- timeFrame
- During surgery
- description
- Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years of age), * with diagnosis of cutaneous melanoma and * in which SLNB is indicated as a staging method, and * with cN0 result after clinical-echographic-cytohistological evaluation. Exclusion Criteria: * Previous treatment with systemic therapy. * Recent previous surgery (\<3 months) in the area susceptible of lymphatic drainage from the melanoma. * Intolerance or hypersensitivity to iron or dextran compounds. * Impossibility of use of radioisotope. * Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin). * Implantation of pacemakers or partially or totally metallic thoracic implants. * Treatment with iron chelators (deferasirox, deferoxamine, ...).
References
Publications (0)
Data not yet available
No reference posted for this study.