Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

• Conditions: Melanoma Stage; Sentinel Lymph Node

• Registration Number: NCT03449615
• Lead Sponsor: Sociedad Española de Oncología Quirúrgica

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

Study Timeline

• Study Start: 2015-12-21
• Status Verified: 2018-02
• Study First Submitted: 2018-02-17
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01
• Primary Completion: 2018-05
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• 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 Criteria

• 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, ...).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SN detection	During surgery	Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria.

Secondary Outcome Measures

Name	Time	Method
SN agreement	During surgery	Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).

Trial Locations

Locations (1)

Hospital Clínico Universitario "Virgen de la Arrixaca"; 🇪🇸 Murcia, Spain