Spots Global Cancer Trial Database for Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
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Trial Identification
Brief Title: Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
Official Title: Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
Study ID: NCT03449615
Interventions
Study Description
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. Both methods are used in every included patient and each patient is its own control.
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 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Clínico Universitario "Virgen de la Arrixaca", Murcia, , Spain
Contact Details
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