A Feasibility Study of Hypoxia Imaging in Patients With Lung Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy
研究概览
简要总结
The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans can provide useful information about hypoxia in lung cancer.
In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior to their first radiotherapy treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with stage II or III lung cancer (both NSCLC and SCLC) qualifying for radiotherapy to the primary tumor, with or without treatment of mediastinal or hilar lymph nodes
- •Intention to treat using radiotherapy according to the current treatment policies of the PMH Lung Group
- •Concurrent systemic therapy allowed
- •A negative serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
- •Ability to provide written informed consent to participate in the study
排除标准
- •Previous radiotherapy to intended treatment volumes.
- •Previous systemic therapy
- •Active malignancy other than lung cancer
- •Unable to remain supine for more than 60 minutes
- •Age less than 18 years old
- •Failure to provide written informed consent
研究组 & 干预措施
18-F-FAZA Scan
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
干预措施: 18-F-FAZA (Biological)
结局指标
主要结局
Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy
时间窗: 5 years
Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake
时间窗: 5 years
次要结局
- Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy(5 years)