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Trial record 16 of 24 for:    Feridex

Validation of Ferromagnetic Tracer in Melanoma Sentinel Node (IMINEM)

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ClinicalTrials.gov Identifier: NCT03449615
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Sysmex España
Information provided by (Responsible Party):
Antonio Piñero-Madrona, 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.

Condition or disease
Melanoma Stage Sentinel Lymph Node

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 Type : Observational
Estimated Enrollment : 186 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
Actual Study Start Date : December 21, 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  1. SN detection [ Time Frame: 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 :
  1. SN agreement [ Time Frame: During surgery ]
    Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.
Criteria

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, ...).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449615


Contacts
Contact: Antonio Piñero Madrona, MD PhD pineromadrona@gmail.com

Locations
Spain
Hospital Clínico Universitario "Virgen de la Arrixaca" Recruiting
Murcia, Spain, 30120
Contact: Antonio Piñero Madrona, MD PhD       pineromadrona@gmail.com   
Principal Investigator: Antonio Piñero Madrona, MD PhD         
Principal Investigator: Jacobo Cabañas, MD PhD         
Principal Investigator: Antonio R Rull, MD PhD         
Principal Investigator: Roberto Rodriguez, MD PhD         
Principal Investigator: Jesús Hernández Gil, MD PhD         
Sponsors and Collaborators
Sociedad Española de Oncología Quirúrgica
Sysmex España

Responsible Party: Antonio Piñero-Madrona, SEOQ Researcher, Sociedad Española de Oncología Quirúrgica
ClinicalTrials.gov Identifier: NCT03449615     History of Changes
Other Study ID Numbers: SEOQ-MEL001
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Piñero-Madrona, Sociedad Española de Oncología Quirúrgica:
Cutaneous melanoma
Sentinel node biopsy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas