Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Sentinel Node detection rate
研究概览
简要总结
The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor < 4 cm.
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 primary vulva cancer, FIGO stage IB (tumor < 4 cm)
- •Patients with unifocal recurrence in the vulva (tumor < 4 cm) located on the side where the patient is surgically naïve in the groin
排除标准
- •Prior irradiation of the vulva or groins
- •Prior SNB or inguinal lymphadenectomy in the relevant groin
- •Known allergy to ICG or iodine (ICG contains 5% sodium iodine)
结局指标
主要结局
Sentinel Node detection rate
时间窗: Three years
SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor \< 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.
次要结局
- Sensitivity, specificity, PPV and NPV(Three years)
研究者
Ligita Paskeviciute Froding
Principal Investigator
Rigshospitalet, Denmark