Status:
UNKNOWN
Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
Lead Sponsor:
Sociedad Española de Oncología Quirúrgica
Collaborating Sponsors:
Sysmex España
Conditions:
Melanoma Stage
Sentinel Lymph Node
Eligibility:
All Genders
18+ years
Brief Summary
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. Bot...
Detailed Description
* 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 minut...
Eligibility Criteria
Inclusion
- 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
- 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, ...).
Key Trial Info
Start Date :
December 21 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03449615
Start Date
December 21 2015
End Date
September 1 2018
Last Update
March 1 2018
Active Locations (1)
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1
Hospital Clínico Universitario "Virgen de la Arrixaca"
Murcia, Spain, 30120