Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Tumor to Background Ratio (TBR)
研究概览
简要总结
This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.
详细描述
This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2-5.
After completion of study, patients are followed up at days 10 and 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
50 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Cetuximab (Biological)
50 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Cetuximab-IRDye 800CW (Drug)
50 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Tumor resection (Procedure)
100 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Cetuximab (Biological)
100 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Cetuximab-IRDye 800CW (Drug)
100 mg cetuximab-IRDye 800
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
干预措施: Tumor resection (Procedure)
结局指标
主要结局
Tumor to Background Ratio (TBR)
时间窗: 1 day
Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.
次要结局
- Incidence of Adverse Events(Up to 30 days)
研究者
Eben Rosenthal
Professor of Otolaryngology
Stanford University