Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Tumor to normal tissue (T:N) ratios
研究概览
简要总结
Rationale: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.
Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV squamous cell cancer of the oral cavity, oropharynx, and larynx.
详细描述
Detailed DescriptionPRIMARY OBJECTIVES:
I. Describe the patterns and levels of 18F-EF5 in Stage 1 - 4 de novo HNSCC of the oral cavity, oropharynx and larynx.
II. Determine whether the 18F-EF5 PET images are predictive of patient outcome (event-free survival; EFS and overall survival; OS).
III. Determine whether any statistically significant prognostic relationships found in the corresponding grant are independent of nodal status.
SECONDARY OBJECTIVES:
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
- •Patients must have a histologically confirmed and/or clinical and imaging evidence of a Stage 1-4 de novo mass in the larynx, pharynx or oral cavity
- •Treatment plan should include Surgery (Biopsy or Excision) and may be followed by radiation and/ or concurrent chemotherapy
- •Patients' disease must not require emergency surgical attention
- •The need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
- •Patients must have a Karnofsky performance status >= 70
- •Patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
- •Patients must have normal organ and marrow function as defined below:
- •WBC > 2,000/mm^3
- •Platelets > 100,000/mm^3
- •Total bilirubin
- •Creatinine
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
- •Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Serum pregnancy testing will be required for women of childbearing age
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
- •Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant women and women who are breastfeeding
- •Patients whose clinical status requires that surgery for their HNSCC be performed emergently or in a time course that does not allow scheduling of an 18F-EF5 PET scan preceding surgery and chemoradiation
研究组 & 干预措施
Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
干预措施: fluorine F18 EF5 (Drug)
Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
干预措施: immunohistochemistry staining method (Procedure)
Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
干预措施: biopsy (Procedure)
Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
干预措施: Positron Emission tomography (Procedure)
结局指标
主要结局
Tumor to normal tissue (T:N) ratios
时间窗: Study completion
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
18F-EF5 standardized uptake values (SUV)
时间窗: Study completion
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
次要结局
- Event-free survival and overall survival(5 years)