EUCTR2020-000819-67-GB进行中(未招募)1 期
SENTINUS: Technical feasibility and diagnostic accuracy of intradermal microbubbles and contrast enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients following training and mentorship of imaging specialists - SENTINUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically confirmed invasive carcinoma of the breast without palpable axillary lymph nodes with planned
- •primary surgical treatment.
- •Normal B-mode axillary ultrasound or benign biopsy of morphologically abnormal lymph nodes.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Aged 18 years or above.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Previous ipsilateral breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
- •Female participant who is pregnant, lactating or planning fertility preservation during the course of the
- •Allergy to contrast.
- •Inflammatory or locally advanced breast cancer.
- •Metastatic breast cancer.
- •Inability to raise ipsilateral arm above head.
- •Multiple medical co-morbidities (ASA 4 or above).
- •Previous ipsilateral axillary surgery.
研究者
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