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Validation of Ferromagnetic Tracer in Melanoma Sentinel Node (IMINEM)

S

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, ...).

Trial contacts and locations

1

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Central trial contact

Antonio Piñero Madrona, MD PhD

Data sourced from clinicaltrials.gov

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