Validation of Ferromagnetic Tracer in Melanoma Sentinel Node (IMINEM)

Sociedad Española de Oncología Quirúrgica

Status: Unknown

Conditions: Sentinel Lymph Node; Melanoma Stage

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03449615

SEOQ-MEL001

Details and patient eligibility

About

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.

Full 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

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, ...).