Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Safety of F-18-EF5 based on the NCI CTCAE version 3.0
研究概览
简要总结
This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed brain tumors undergoing surgery or biopsy.
Secondary I. Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered before and after nonradioactive EF5 in these patients.
II. Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to detect tumor hypoxia in these patients.
III. Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.
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
- •Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
- •Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor
- •Performance status - Karnofsky 70-100%
- •At least 3 months
- •WBC count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 1.2 mg/dL
- •Creatinine < 1.3 mg/dL
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other significant cardiac condition that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study participation
- •Weight ≤ 130 kg
- •No peripheral neuropathy ≥ grade 3
- •No history of allergic reaction attributed to metronidazole
- •No other uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No other medical condition that would preclude study participation
排除标准
- 未提供
研究组 & 干预措施
Group 1 (fluorine F 18 EF5, PET)
Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
干预措施: conventional surgery (Procedure)
Group 1 (fluorine F 18 EF5, PET)
Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
干预措施: positron emission tomography (Procedure)
Group 1 (fluorine F 18 EF5, PET)
Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
干预措施: fluorine F 18 EF5 (Radiation)
Group 1 (fluorine F 18 EF5, PET)
Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
干预措施: pharmacological study (Other)
Group 2 (EF5, PET)
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
干预措施: EF5 (Drug)
Group 2 (EF5, PET)
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
干预措施: conventional surgery (Procedure)
Group 2 (EF5, PET)
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
干预措施: positron emission tomography (Procedure)
Group 2 (EF5, PET)
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
干预措施: pharmacological study (Other)
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
干预措施: EF5 (Drug)
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
干预措施: conventional surgery (Procedure)
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
干预措施: positron emission tomography (Procedure)
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
干预措施: fluorine F 18 EF5 (Radiation)
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
干预措施: pharmacological study (Other)
结局指标
主要结局
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
时间窗: Up to 3 years
Summarized in descriptive statistics.
次要结局
- Pharmacokinetics of radioactively labeled [F-18]-EF5(Day 1)
- Extent of hypoxia, determined by [F-18]-EF5 PET imaging(Up to day 1)
- IHC analysis of cold EF5(Up to day 1)
- Progression-free survival(Up to 6 years)