A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 8
- 主要终点
- To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
研究概览
简要总结
The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.
An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
时间窗: 4 months
For Cohort 1
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
时间窗: 4 months
For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
时间窗: At baseline
Cohort 2
次要结局
- To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.(2 weeks from time of scan)