Computed Tomography for Coronavirus Disease 19 Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,735
- 试验地点
- 1
- 主要终点
- Predictive values of CT criteria
研究概览
简要总结
The purpose of this study is to build a large dataset of Computed Tomography (CT) images for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
详细描述
The outbreak of the novel coronavirus SARS-CoV-2, initially epicentred in China and responsible for COVID-19 pneumonia has now spread to France, with 7730 confirmed cases and 175 deaths as on March 17th. Diagnosis relies on the identification of viral RNA by reverse-transcription polymerase chain reaction (RT-PCR), but its positivity can be delayed. A series based on 1014 chinese patients reported higher sensitivity for CT, with a mean interval time between the initial negative to positive RT-PCR results of 5.1 ± 1.5 days (PMID: 32101510). Moreover, obtaining RT-PCR results requires several hours, which is problematic for patients triage.
Chest CT can allow early depiction of COVID-19, especially when performed more than 3 days after symptoms onset. It is important to distinguish between COVID-19 and bacterial causes of pulmonary infection, which requires expertise in thoracic imaging. Thus, it is important to identify reliable CT diagnostic criteria based on visual assessment, and also develop deep-learning based solutions for early positive diagnosis which could be used by less experienced readers, in a context of large epidemic.
Several risk factors for poor outcome are already identified, such as older age, comorbidities, or an elevated d-dimer level at presentation (PMID: 32171076). Extensive CT abnormalities are linked to poor outcome, but some patients secondarily worsen despite non extensive abnormalities at first assessment, highlighting the need for worsening prediction based on initial imaging findings. Lastly, there is currently no drug with a proven efficacy for patients with acute respiratory distress syndrome, who for management relies on mechanical ventilation and supportive care. Some hypothesized that Remdesivir, an antiviral therapy could be effective (PMID: 32147516), with ongoing randomized trials conducted in China and the US. Automated tools allowing quantifying the disease extent on CT would be desirable in order to evaluate the efficacy of new treatments.
Building a large dataset of CT images is needed for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
The aim of this project is three fold: (i) create a multi-centric open database repository on CT scans relative to COVID-19, (ii) create a multi-expert annotation protocol with different level of annotations depicting the severity of the disease, (iii) allow the development of non-proprietary computer aided solutions (academia & industry) for automatic quantification of the diseases and prognosis through the use of the latest advances in the field of artificial intelligence.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •CT examination performed for suspicion or follow-up of COVID-19
- •Non opposition for use of data
排除标准
- •Unavailability of RT-PCR results for SARS-Cov-2
- •Failure of CT image anonymized export
结局指标
主要结局
Predictive values of CT criteria
时间窗: 1 month
Sensibility specificity positive and negative predictive values of CT criteria with RT-PCR results as standard of reference.
次要结局
- Accuracy of deep-learning based score(1 month)
- Dice similarity coefficient between manual and automated segmentation of lung disease abnormalities(1 month)
- Accuracy of CT composite severity score(1 month)
- Predictive values of deep-learning based diagnostic algorithms(1 month)
