NCT03449615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

February 17, 2018

Last Update Submit

February 28, 2018

Conditions

Melanoma StageSentinel Lymph Node

Keywords

Cutaneous melanomaSentinel node biopsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • SN agreement

    During surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.

You may qualify if:

  • 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.

You may not qualify if:

  • 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, ...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario "Virgen de la Arrixaca"

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Antonio Piñero Madrona, MD PhD

CONTACT

pineromadrona@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SEOQ Researcher

Study Record Dates

First Submitted

February 17, 2018

First Posted

February 28, 2018

Study Start

December 21, 2015

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

ES(1)