Assessment of Hypoxia in Malignant Gliomas Using EF5
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to local recurrence
研究概览
简要总结
This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
详细描述
PRIMARY OBJECTIVES:
I. Determine the presence and pattern of etanidazole derivative EF5 binding with tumor, based on image and cellular analyses, in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas.
II. Determine the level of EF5 binding within histologic subtypes of this tumor in these patients.
Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme (GBM) vs non-GBM.
III. Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.
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
- •Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma
- •Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy
- •Performance status - Karnofsky performance status 60-100%
- •WBC greater than 2,000/mm^3
- •Platelet count greater than 90,000/mm^3
- •Creatinine less than 2.0 mg/dL
- •No significant cardiac condition that would preclude study therapy
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study completion
- •Weight no greater than 130 kilograms
- •No grade 3 or 4 peripheral neuropathy
- •No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis
- •No uncontrolled concurrent illness, medical condition, psychiatric illness, or social situation that would preclude study participation
- •At least 6 months since prior chemotherapy
- •Concurrent corticosteroid therapy allowed
- •At least 6 months since prior radiotherapy to lesion or site of lesion
- •At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy
- •Concurrent anticonvulsant therapy allowed
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
干预措施: etanidazole (Drug)
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
干预措施: conventional surgery (Procedure)
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
干预措施: pharmacological study (Other)
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Time to local recurrence
时间窗: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
次要结局
- Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses(At 48 hours after EF5 administration)
- Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)(Up to 3 years)
- Time to death(Up to 3 years)
- Association between EF5 binding and Eppendorf needle electrode measurements in brain masses(Up to 3 years)
- Levels of EF5 binding within histological subtypes of SMG(At baseline, at 1 hour, and the time of surgery)