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| Name | Class |
|---|---|
| Sysmex España | INDUSTRY |
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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:
Ex vivo check and HRD record
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| Measure | Description | Time Frame |
|---|---|---|
| SN detection | Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| SN agreement | Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes). | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Piñero Madrona, MD PhD | Contact | pineromadrona@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario "Virgen de la Arrixaca" | Recruiting | Murcia | 30120 | Spain |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |