Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.

Recruiting

• Conditions: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe

• Registration Number: NCT06261983
• Lead Sponsor: Hospital Donostia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Josué Hernando Vázquez; 🇪🇸 Donostia, Guipuzkoa, Spain