Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lymph node count to background ratio 24 hours post-injection
研究概览
简要总结
A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Early stage breast cancer (T1, T2)
- •Clinically node negative (no enlarged axillary lymph nodes)
排除标准
- •Prior surgery in same breast
- •Pregnancy or breastfeeding
研究组 & 干预措施
Injection of 99m-Tc Tilmanocept
干预措施: Tilmanocept (Drug)
Injection of 99m-Tc Nanocolloid
干预措施: Nanocolloid (Drug)
结局指标
主要结局
Lymph node count to background ratio 24 hours post-injection
时间窗: 20 to 24 hours post-injection
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection
Injection site count to background ratio 4 hours post-injection
时间窗: 4 hours post-injection
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
Injection site count to background ratio 24 hours post-injection
时间窗: 20 to 24 hours post-injection
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection
Time to identification of first lymph node
时间窗: 0-30 minutes
Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
Lymph node count to background ratio 4 hours post-injection
时间窗: 4 hours post-injection
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection
次要结局
未报告次要终点