Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Accuracy of intraoperative ICG fluorescence compared to final pathology results
研究概览
简要总结
This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.
OUTLINE: This is an observational study.
Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection
排除标准
- •Chronic kidney disease
- •Anaphylaxis to dyes
研究组 & 干预措施
Observational
Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Accuracy of intraoperative ICG fluorescence compared to final pathology results
时间窗: Baseline
Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.
次要结局
未报告次要终点