Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Spatial coordination as measured by EF5 binding at completion of accrual
研究概览
简要总结
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.
PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.
详细描述
OBJECTIVES:
- Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
- Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
- Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
- Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
- Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EF5
This is a non randomised single arm pilot study.
干预措施: biopsy (Procedure)
EF5
This is a non randomised single arm pilot study.
干预措施: EF5 (Drug)
EF5
This is a non randomised single arm pilot study.
干预措施: bioluminescence (Other)
EF5
This is a non randomised single arm pilot study.
干预措施: flow cytometry (Other)
EF5
This is a non randomised single arm pilot study.
干预措施: immunohistochemistry staining method (Other)
结局指标
主要结局
Spatial coordination as measured by EF5 binding at completion of accrual
时间窗: One Year
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual
时间窗: One Year
Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual
时间窗: One year
Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual
时间窗: One Year
Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual
时间窗: One year
次要结局
未报告次要终点
研究者
David M. Brizel, MD
Professor
Duke University