French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 6
- 主要终点
- Sentinel lymph node detection rate
研究概览
简要总结
This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.
The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.
The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).
The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.
The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Aged ≥18 years
- •Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy
- •Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or 99mTc) for intraoperative identification of sentinel lymph node according to the Summary of Product Characteristics
排除标准
- •Pregnant or nursing female
- •Previous allergy to indocyanine green or to any excipients
- •Already included in a surgical trial
- •Patient opposed to collection and processing of their data
结局指标
主要结局
Sentinel lymph node detection rate
时间窗: Time of Surgery
Rate of detection of at least one sentinel lymph node by indocyanine green
次要结局
- Weight(At visit 1 (pre-operative consultation))
- Comorbidities(At visit 1 (pre-operative consultation))
- Tumour laterality(At visit 1 (pre-operative consultation))
- Detection equipment(Time of surgery)
- Number of sentinel lymph nodes detected - blue dye(Time of surgery)
- Number of sentinel lymph nodes detected - 99mTc(Time of surgery)
- BMI(At visit 1 (pre-operative consultation))
- Tumour size(At visit 1 (pre-operative consultation))
- Tumour quadrant(At visit 1 (pre-operative consultation))
- Indocyanine green dose(Time of surgery)
- Injection site(Time of surgery)
- Route of injection(Time of surgery)
- Time from injection to visualization(Time of surgery)
- Number of sentinel lymph nodes detected - indocyanine green(Time of surgery)
- Height(At visit 1 (pre-operative consultation))
- Prior excisional surgery(At visit 1 (pre-operative consultation))
- Surgery type planned(At visit 1 (pre-operative consultation))
- Histological type(At visit 1 (pre-operative consultation))
- Number of injection sites(Time of surgery)
- Number of sentinel lymph node biopsies performed(Time of surgery)
- Time from injection to end of biopsy(Time of surgery)
- Adverse events(From time of surgery up to 6 weeks post-surgery)
- Tumour stage(At visit 1 (pre-operative consultation))
- Age(At visit 1 (pre-operative consultation))
- Menopause status(At visit 1 (pre-operative consultation))
- Tumour grade(At visit 1 (pre-operative consultation))
- Hormone receptor status(At visit 1 (pre-operative consultation))
- Detection method(Time of surgery)
- Indocyanine green volume(Time of surgery)
- Number of sentinel lymph nodes detected(Time of surgery)
- Serious adverse events(From time of surgery up to 6 weeks post-surgery)
- Changes in vital signs(From time of surgery up to 6 weeks post-surgery)