The Diagnostic Power of 18F-FDG PET-CT Scanning for Discriminating Malignant From Non-malignant Causes in Unilateral Pleural Effusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Sensitivity PET-CT
研究概览
简要总结
The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion of unknown origin.
详细描述
The investigators follow the STARD 2015 guideline for reporting diagnostic accuracy studies.
The investigators will review the hospital's administrative database of patients who underwent a thoracocentesis from January 2013 to January 2015. Patients at Department of Respiratory Medicine, Zealand University Hospital, Roskilde and Department of Respiratory Medicine, Naestved Hospital, Region Zealand, Denmark (two large respiratory centres with specialised functions) is eligible for inclusion. Patients are included irrespective of cytology and chemical analysis.
The investigators will review the patients' medical records and images retrospectively. To reduce the number of false negatives, the investigators complete a 1-year follow-up.
Patients older than 16 years are included, irrespective of smoking history and comorbidities, if both thoracocenteses, chest x-ray, a CT-scanning and a PET-CT scanning is performed. Exclusion criteria are previously diagnosed lung cancer, thoracic malignancy or incomplete data.
Classification of results The investigators chose the combination of investigations recommended by the internationally acknowledged BTS guideline, which is endorsed by the Danish Society of Respiratory Medicine. Thoracocentesis, chest x-ray, CT findings and PET-CT findings is categorized as either normal (i.e. not suggestive of any aetiology of the unilateral pleural effusion), suggestive of other lung pathology or suggestive of malignancy (i.e. representing a possible aetiology of the unilateral pleural effusion).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thoracocentesis
- •Chest X-ray
- •CT scanning
- •PET-CT scanning
排除标准
- •Missing data
- •Lung cancer
- •Thoracic malignancies
结局指标
主要结局
Sensitivity PET-CT
时间窗: 1 year
TP / (TP + FN)
次要结局
- CT-Sensitivity(1 year)
- Comparison of the diagnostic power(1 year)
- CT-Specificity(1 year)
- PET-CT-Specificity(1 year)
- PET-CT-Likelihood ratio+(1 Year)
- CT-positive predictive value(1 year)
- CT-negative predictive value(1 year)
- PET-CT-negative predictive value(1 year)
- CT-Diagnostic accuracy(1 year)
- PET-CT-Diagnostic accuracy(1 year)
- CT-Likelihood ratio+(1 Year)
- CT-Likelihood ratio-(1 year)
- PET-CT-Likelihood ratio-(1 year)
- PET-CT-positive predictive value(1 year)
研究者
Simon Reuter
MD, Principal investigator
Naestved Hospital
