Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
研究概览
简要总结
Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.
Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.
One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.
The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.
- •Age >18 years.
- •Written informed consent.
排除标准
- •Pregnancy.
- •Prior treatment for this tumor
- •Women breast feeding
结局指标
主要结局
To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
时间窗: 1 month
次要结局
- To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.(1 month)