DAHANCA 24: Prognostic Value of 18F-FAZA Positron Emission Tomography After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Can 18F-FAZA can be used as a prognostic marker in HNSCC?
研究概览
简要总结
Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with poor local control and survival, as hypoxia is a cause of resistance to radio- and chemotherapy and the development of a more aggressive tumour.
Previous attempts to measure hypoxia have been biased because the techniques have been invasive, not repeatable or difficult to apply on a routine basis. There is great interest in trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying therapy and prediction of treatment response. Additionally the investigators' knowledge of change in hypoxia over time is limited, but of great interest as individualised treatment, such as intensity-modulated radiation therapy (IMRT) is emerging.
18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles, 18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer image of hypoxia.
The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.
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
- •Histological proven squamous cell carcinoma of the pharynx, larynx, oropharynx and hypopharynx
- •Curative intent and no prior treatment
- •Age >= 18 years
- •stage T1-4 N0-N3 M
- •Informed consent according to local guidelines and national law
- •The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
- •Fertile women must use contraceptive devices (IUD or oral contraceptives)
排除标准
- •No serious concurrent medical disease
- •No metastasis
- •No prior disease that can affect the treatment, evaluation or outcome of current disease
- •No pregnant or breastfeeding woman
结局指标
主要结局
Can 18F-FAZA can be used as a prognostic marker in HNSCC?
时间窗: 1, 5 years
次要结局
- Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy(Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation)