Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma. (SentiMag)

February 8, 2024 updated by: Josue Hernando, Hospital Donostia

Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study

Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

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
    • Guipuzkoa
      • Donostia, Guipuzkoa, Spain, 20011
        • Recruiting
        • Josué Hernando Vázquez
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital.

Description

Inclusion Criteria:

  • Oral squamous cell carcinoma T1-T2, cN0.
  • Absence of alterations to iron metabolism.

Exclusion Criteria:

  • Previous neck surgery.
  • Treatment with iron chelators.
  • Pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with oral squamous cell carcinoma at stages I-II
The patients underwent sentinel node biopsy and posterior neck dissection
Procedure: Sentinel node biopsy guided by magnetic probe
Sentinel nodes exeresis guided by magnetic probe after injection submucosally and peritumorally of super-para-magnetic contrast. Standard neck dissection (levels I-II) were carry out after sentinel node biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).
Time Frame: Six years
Six years

Collaborators and Investigators

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

Sponsor

Hospital Donostia

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)

October 1, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019111032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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