Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of FGD-PET/CT to detect the primary tumor
研究概览
简要总结
Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.
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
- •Histopathological proven head and neck carcinoma
- •Written inform consent
- •18 years of age
排除标准
- •Cancer of unknown primary
- •En-bloc resection of lymph node levels
- •Uncertainties regarding the removed lymph node levels
结局指标
主要结局
Diagnostic accuracy of FGD-PET/CT to detect the primary tumor
时间窗: 2013-2018
Visual assessment of FDG-PET/CT will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect the primary tumor.
Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases
时间窗: 2013-2018
Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases.
Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases.
时间窗: 2013-2018
Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence, localization and number of distant nodal metastasis will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases.
次要结局
- Diagnostic accuracy of MRI to detect lymph nodes metastases(2013-2018)
- Diagnostic accuracy of CT to detect distant lymph node metastases.(2013-2018)
- Diagnostic accuracy of MRI to detect the primary tumor(2013-2018)
- Diagnostic accuracy of CT to detect the primary tumor(2013-2018)
- Diagnostic accuracy of CT to detect lymph nodes metastases(2013-2018)