Use of [18]F-FDG - PET/CT in Brazil Unified Health System (SUS) as an Alternative Non-invasive Method for Staging of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
研究概览
简要总结
To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.
详细描述
The main aim of this study is to validate the [18F]FDG on PET/CT for the diagnosis of metastatic ganglions at the mediastinum in SUS patients with non-small cell lung carcinoma considering sensitivity, specificity, positive predictive value, negative predictive value, accuracy. Other specific aims are:
- Analyze the diagnosis performance of the [18F]FDG on PET/CT in two timepoints (1 and 2 hours after exam), in relation to the staging of the non-small cell lung carcinoma
- Evaluate the addition of the iodinated contrast in the [18F]FDG to improve the images obtained from the PET/CT in the staging of the non-small cell lung carcinoma
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
- •Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma
- •Patients who previously underwent staging of the disease with CT
- •Clinical stages I-III AJCC 7th edition.
- •Patients with indication for mediastinoscopy and linfonodal biopsy
- •Patients without treatment for lung cancer
- •Patients with biochemical and haematological exams
- •Women of childbearing potential using contraceptive methods and negative pregnancy test
- •Adults with more than 18 years old.
- •Both genders
排除标准
- •Pregnant women
- •Patients with other types of patients
研究组 & 干预措施
Diagnosis or suspicion of non-small cell lung carcinoma
SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy
干预措施: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma (Other)
结局指标
主要结局
Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
时间窗: 4 years
次要结局
- Number of true positives among positive diagnosed patients with the alternative method(up to 30 days following recruitment)
- Number of false positives among patients negatively diagnosed with the alternative method(up to 30 days following recruitment)
- Number of patients diagnosed in a positive manner with the gold standard and with the alternative method(up to 30 days following recruitment)
- Number of patients with a negative diagnosis according to the gold standard and the alternative method(up to 30 days following recruitment)