Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Sentinel Lymph Node Clinical Trial

— IMINEM  

Official title:

Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03449615
• Other study ID #: SEOQ-MEL001
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2018
• Last updated: February 28, 2018
• Start date: December 21, 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2018
• Source: Sociedad Española de Oncología Quirúrgica
• Contact: Antonio Piñero Madrona, MD PhD
• Email: pineromadrona[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ...).

Related Conditions & MeSH terms

• Melanoma
• Melanoma Stage
• Sentinel Lymph Node

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario "Virgen de la Arrixaca"	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Oncología Quirúrgica	Sysmex España

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SN detection	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	SN agreement	Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).	During surgery