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Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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Inclusion Criteria:
Exclusion Criteria:
- - Treatment with iron chelators.
- PregnantTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
: Patients diagnosed with oral squamous cell carcinoma at stages I-II
The patients underwent sentinel node biopsy and posterior neck dissection
Interventions
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
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Josué Hernando Vázquez
Donostia, Guipuzkoa, 20011
Site Contact
Josué Hernando, PhD, DDS
[email protected]
0034 675825482
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