Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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, .

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sociedad Española de Oncología Quirúrgica
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma Stage, Sentinel Lymph Node
Additional Details

  • - Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
  • - Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
  • - Optional: colorant injection in standard form.
Local massage of 5-10 minutes.
  • - After 20 minutes: transcutaneous measurement with SentiMag® - Valuing territories (lymphoscintigraphy information?) - Surgical identification measures: 1.
st with SentiMag® 2. nd with gamma detection probe - Ex vivo check and HRD record

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Murcia, Spain




Hospital Clínico Universitario "Virgen de la Arrixaca"

Murcia, , 30120

Site Contact

Antonio Piñero Madrona, MD PhD

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