Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-21

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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* 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

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Melanoma Stage Sentinel Lymph Node

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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, ...).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No