NCT02306967已完成不适用
Fluorescent Visualization in Early Oral Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- disease specific survival
研究概览
简要总结
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •biopsy proven invasive oral cancer or severe dysplasia / Cis
- •invasive cancer must be T1 or T2
- •no prior history of oral cancer / treatment of oral cancer
排除标准
- •prior history of oral cancer
- •unable to provide informed consent
- •lesion not able to be completely visualized by FV
研究组 & 干预措施
Standard Resection
Active Comparator
Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer.
干预措施: resection of oral cancer (Procedure)
FV Guided Resection
Experimental
The oral resection will be guided by fluorescent visualization (FV).
干预措施: resection of oral cancer (Procedure)
结局指标
主要结局
disease specific survival
时间窗: 5 years
disease specific 5 year survival
次要结局
未报告次要终点
研究者
Joseph C. Dort
Professor of Surgery
University of Calgary
研究点 (2)
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