A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Signal-to-background ratio (SBR)
研究概览
简要总结
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.
详细描述
Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer, adults
排除标准
- •Patient aged < 20 years old
- •Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
- •Patient who is allergic to primary tracers (including Tc99m and blue dye)
- •Patient who is allergic to indocyanine green
研究组 & 干预措施
Voluven diluted indocyanine green
This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.
干预措施: Near infrared fluorescence navigated sentinel lymph node mapping (Procedure)
Distilled-water diluted indocyanine green
This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.
干预措施: Near infrared fluorescence navigated sentinel lymph node mapping (Procedure)
结局指标
主要结局
Signal-to-background ratio (SBR)
时间窗: through study completion, an average of 1 year
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Penetration depth
时间窗: through study completion, an average of 1 year
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
次要结局
- Time to total visualization of breast subcutaneous lymphatics(through study completion, an average of 1 year)
- Sentinel lymph nodes pathology(through study completion, an average of 1 year)