An observational study in Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe, sponsored by Hospital Donostia. Recruiting at 1 site in Spain. Open to participants aged 29 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Hospital Donostia · Observational
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.
Hospital Donostia is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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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.
Exclusion Criteria:
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
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
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