A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
研究概览
简要总结
According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18 years of age
- •Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment
- •Good operative candidate as determined by the treating physician and multidisciplinary team
- •Subject capable of giving informed consent and participating in the process of consent.
排除标准
- •Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- •Subjects with a history of iodide allergies
- •Vulnerable patient populations
- •People who would be easily lost to follow up
- •Patients unable to participate in the consent process (children and neonates).
研究组 & 干预措施
ICG injection group
This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed.
干预措施: Indocyanine Green (ICG) (Drug)
结局指标
主要结局
The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
时间窗: Before surgery
次要结局
- The number of participants that will have an adverse reaction to the ICG.(Day 1-Day 30)
研究者
Sunil Singhall
Assistant Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab
University of Pennsylvania