Validation of Ferromagnetic Tracer in Melanoma Sentinel Node (IMINEM)

February 28, 2018 updated by: Antonio Piñero-Madrona, Sociedad Española de Oncología Quirúrgica

Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario "Virgen de la Arrixaca"
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Oncología Quirúrgica

Collaborators

Sysmex España

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2015

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

February 17, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (ACTUAL)

February 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEOQ-MEL001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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