Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Sensitivity of the CEUS SN localization method
研究概览
简要总结
This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head & neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
- •Pregnancy
- •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 of the CEUS SN localization method
时间窗: 1 day
To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method?
次要结局
未报告次要终点