IMINEM: Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Sponsor

Sociedad Española de Oncología Quirúrgica (Other)

Overall Status

Unknown status

CT.gov ID

NCT03449615

Collaborator

Sysmex España (Industry)

186

Enrollment

Location

32.4

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

st with SentiMag®
nd with gamma detection probe

Ex vivo check and HRD record

Study Design

Study Type:

Observational

Anticipated 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 :

Dec 21, 2015

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Outcome Measures

Primary Outcome Measures

SN detection [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

SN agreement [During surgery]
Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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, ...).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico Universitario "Virgen de la Arrixaca"	Murcia		Spain	30120

Sponsors and Collaborators

Sociedad Española de Oncología Quirúrgica
Sysmex España

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Piñero-Madrona, SEOQ Researcher, Sociedad Española de Oncología Quirúrgica

ClinicalTrials.gov Identifier:

NCT03449615

Other Study ID Numbers:

SEOQ-MEL001

First Posted:

Feb 28, 2018

Last Update Posted:

Mar 1, 2018

Last Verified:

Feb 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antonio Piñero-Madrona, SEOQ Researcher, Sociedad Española de Oncología Quirúrgica

Cutaneous melanoma

Sentinel node biopsy

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Mar 1, 2018