Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03449615

Acronym

IMINEM

Enrollment

186

Registered

2018-02-28

Start date

2015-12-21

Completion date

2018-09-30

Last updated

2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma Stage, Sentinel Lymph Node

Keywords

Cutaneous melanoma, Sentinel node biopsy

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.

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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, ...).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Spain

Contacts

Primary ContactAntonio Piñero Madrona, MD PhD

pineromadrona@gmail.com

Outcome results