Clinical Trials Directory

Trials / Unknown

UnknownNCT06261983

Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.

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

Status
Unknown
Phase
Study type
Observational
Enrollment
24 (estimated)
Sponsor
Hospital Donostia · Academic / Other
Sex
All
Age
29 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESentinel node biopsy guided by magnetic probeSentinel 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

Timeline

Start date
2018-10-01
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2024-02-15
Last updated
2024-02-15

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06261983. Inclusion in this directory is not an endorsement.