Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events
研究概览
简要总结
Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.
详细描述
This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panitumumab IRDye 800
Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.
干预措施: IMAGE1 + ICG Hopkins telescope and/or VITOM (Device)
Panitumumab IRDye 800
Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.
干预措施: Panitumumab IRDye 800 (Drug)
Panitumumab IRDye 800
Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.
干预措施: da Vinci Firefly (Device)
结局指标
主要结局
Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events
时间窗: 30 days
Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
次要结局
- Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio(7 days)
- Optimal timing of the surgical procedure to maximize tumor to background ratio(7 days)
研究者
Eben Rosenthal
Professor of Otolaryngology
Stanford University