NCT03146117终止不适用
Application of Integrated PET and Dual Energy CT Imaging for Staging and Imaged Based Radiotherapy Treatment Planning in Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- PET-CT accuracy for lung tumor and thoracic adenopathy detection
研究概览
简要总结
The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.
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
- •To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- •Subject must have a suspected SCLC or NSCLC.
- •Subject must be 18-90 years of age.
- •Subject must have been referred for a clinically indicated PET-CT.
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
排除标准
- •The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
- •Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- •By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
- •By surgical sterilization, or
- •Post-menopausal, with minimum one (1) year history without menses.
- •Subject has impaired renal function (eGFR<30 mL/min).
- •Subject has an acute psychiatric disorder or is cognitively impaired.
- •Subject is using or is dependent on substances of abuse.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject has an allergy against iodinated contrast agents and cannot be premedicated.
- •Subject is in acute unstable condition.
结局指标
主要结局
PET-CT accuracy for lung tumor and thoracic adenopathy detection
时间窗: One year
Knowledge gained during this study may potentially allow for an improvement in PET-CT accuracy for lung tumor and thoracic adenopathy detection, and for a more accurate definition of the RT target, decreasing the radiation dose delivered to normal tissue.
次要结局
未报告次要终点
研究者
研究点 (1)
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