NCT03449615

Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 186 (estimated)
• Sponsor: Sociedad Española de Oncología Quirúrgica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Melanoma Stage
• Sentinel Lymph Node

Timeline

• Start date: 2015-12-21
• Primary completion: 2018-05-01
• Completion: 2018-09-01
• First posted: 2018-02-28
• Last updated: 2018-03-01

Locations

1 site across 1 country: Spain