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临床试验/NCT03272997
NCT03272997已完成不适用

The Diagnostic Power of 18F-FDG PET-CT Scanning for Discriminating Malignant From Non-malignant Causes in Unilateral Pleural Effusions

Naestved Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2017年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Reuter

MD, Principal investigator

Naestved Hospital

研究点 (1)

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