跳至主要内容
临床试验/NCT06261983
NCT06261983招募中不适用

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

Hospital Donostia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
29 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Oral squamous cell carcinoma T1-T2, cN
  • Absence of alterations to iron metabolism.

排除标准

  • Previous neck surgery.
  • Treatment with iron chelators.

结局指标

主要结局

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

时间窗: Six years

次要结局

未报告次要终点

研究者

发起方
Hospital Donostia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josue Hernando

PhD, DDS

Hospital Donostia

研究点 (1)

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