Sentinel Lymph Node Clinical Trial
Official title:
Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
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.
- 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
;
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