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18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung Cancer

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University Health Network, Toronto

关键词

抽象

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

日期

最后验证: 12/31/2019
首次提交: 12/08/2014
提交的预估入学人数: 03/01/2016
首次发布: 03/07/2016
上次提交的更新: 01/23/2020
最近更新发布: 01/26/2020
实际学习开始日期: 11/30/2014
预计主要完成日期: 11/30/2020
预计完成日期: 11/30/2020

状况或疾病

Lung Cancer

干预/治疗

Biological: 18-F-FAZA Scan

-

手臂组

干预/治疗
Experimental: 18-F-FAZA Scan
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
Biological: 18-F-FAZA Scan
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

1. Age ≥ 18 years

2. 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

3. Intention to treat using radiotherapy according to the current treatment policies of the PMH Lung Group

4. Concurrent systemic therapy allowed

5. A negative serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age

6. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Previous radiotherapy to intended treatment volumes.

2. Previous systemic therapy

3. Active malignancy other than lung cancer

4. Unable to remain supine for more than 60 minutes

5. Pregnancy

6. Age less than 18 years old

7. Failure to provide written informed consent

结果

主要结果指标

1. Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy [5 years]

2. Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake [5 years]

次要成果指标

1. Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy [5 years]

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