Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Direct Oxygen Measurements
研究概览
简要总结
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:
- Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
- If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
- Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?
详细描述
Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.
Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
- •Karnofsky performance status greater or equal to 60%
排除标准
- •No prior irradiation or surgery to head/neck area
- •No prior chemotherapy within 1 month of participation and have recovered from associated related effects
- •Not pregnant
- •Any intercurrent medical or physiologic disorder which would prevent informed consent
- •Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
- •Patients with PT or PTT over 1.5 times normal
研究组 & 干预措施
PET + 18F-fluoromisonidazole
干预措施: 18F-fluoromisonidazole (Drug)
PET + 18F-fluoromisonidazole
干预措施: PET scan (Procedure)
结局指标
主要结局
Direct Oxygen Measurements
时间窗: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
次要结局
未报告次要终点
