EUCTR2019-003828-21-NL进行中（未招募）1 期
Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using indocyanine green - INFLUENCE
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
- 100
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
- •- Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by biopsy.
- •- Preoperative axillary ultrasound to confirm clinical node-negative status.
- •- Indication for lumpectomy and SLN procedure.
- •- Written informed consent according to ICH/GCP and national regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •-Patients < 18 years old.
- •-Mastectomy.
- •-Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc) or intravenous contrast, iodine, shellfish.
- •-Other concurrent solid tumor.
- •-Hyperthyroidism or thyroid cancer.
- •-Palliative surgery for locally advanced breast cancer (cT4).
- •-Pregnancy or breast feeding.
- •-Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.
研究者
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