NCT06161428招募中不适用
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size >4 cm, multifocal tumors and local recurrences.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva
排除标准
- •Previous external irradiation of the vulva or groins
- •Former sentinel node or inguinal lymphadenectomy in the relevant groin
- •Known allergy to ICG or iodine
- •Patient is in active treatment for other cancer and/or disseminated disease
结局指标
主要结局
Sensitivity
时间窗: Three years
Sensitivity of sentinel lymph node mapping
次要结局
- Negative predictive value(Three years)
研究者
Ligita Paskeviciute Froding
Principal Investigator
Rigshospitalet, Denmark
研究点 (1)
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