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

H

Hospital Donostia

Status

Enrolling

Conditions

Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe

Treatments

Procedure: Sentinel node biopsy guided by magnetic probe

Study type

Observational

Funder types

Other

Identifiers

NCT06261983
2019111032

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

29 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Patients diagnosed with oral squamous cell carcinoma at stages I-II
Description:
The patients underwent sentinel node biopsy and posterior neck dissection
Treatment:
Procedure: Sentinel node biopsy guided by magnetic probe

Trial contacts and locations

1

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Central trial contact

Josué Hernando, PhD, DDS

Data sourced from clinicaltrials.gov

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