Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Visualisation of tumor hypoxia with [18F] HX4 PET imaging
研究概览
简要总结
The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4 PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after treatment.
详细描述
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, we expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N, M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). Before treatment a standard planning [18F]FDG PET-CT will be performed, a blood sample is drawn and baseline [18F]HX4 PET scans will be performed. 18F-HX4 scans will be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three months after the end of treatment a [18F]FDG PET scan will be performed.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
- •Tumor diameter ≥ 2,5 cm
- •WHO performance status 0 to 2
- •Scheduled for primary curative (concurrent chemo-) radiotherapy
- •No previous surgery to the head and neck
- •No previous radiation to the head and neck
- •Adequate renal function (calculated creatinine clearance at least 60 ml/min).
- •The patient is willing and capable to comply with study procedures
- •18 years or older
- •Have given written informed consent before patient registration
排除标准
- •No recent (< 3 months) myocardial infarction
- •No Uncontrolled infectious disease
- •Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
结局指标
主要结局
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
时间窗: 2 years
Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging
次要结局
- Image quality of [18F] HX4-PET at different time points(2 years)
- Kinetic analysis of HX4(2 years)
- Correlation of hypoxia imaging with blood hypoxia markers(2 years)
- Observe spatial and temporal stability of [18F] HX4 PET images(2 years)
- Correlation of [18F] HX4 with local tumor recurrence and survivalG PET(2 years)
- Correlation of hypoxia imaging with tumor tissue biomarkers(2 years)
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment(2 years)
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment(2 years)