2024-515259-40-00招募中3 期
Contrast-enhanced ultrasound for sentinel node detection in patients with melanoma, breast cancer or head & neck cancer (N24CUS)
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2024年12月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- sensitivity and specificity of the CEUS SN localization method
研究概览
简要总结
To assess the sensitivity and specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Patient has been diagnosed with cancer in the skin (melanoma), breast or head & neck (including melanoma of head and neck area)
- •In case of a melanoma: it should be located in the limbs or head and neck area
- •Scheduled for a surgical SN procedure at the NKI-AvL
- •Patient provides written informed consent
排除标准
- •Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products
- •Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease
结局指标
主要结局
sensitivity and specificity of the CEUS SN localization method
sensitivity and specificity of the CEUS SN localization method
次要结局
- time required to localize the SNs using CEUS in minutes
- usability of the CEUS system using a system-usability-score (SUS)
- sensitivity and specificity of using CEUS to predict if SNs are malignant
研究者
Dr. Q.R.J.G. Tummers
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (1)
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