Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Per-patient detection sensitivity unassisted vs CAD assisted reading
研究概览
简要总结
To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.
详细描述
The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed extra-thoracic neoplasm
排除标准
- •More than 10 nodules
- •Severe pulmonary fibrosis
- •Diffuse bronchiectasis
- •Extensive inflammatory consolidation
- •Massive pleural effusion
- •Pregnancy
结局指标
主要结局
Per-patient detection sensitivity unassisted vs CAD assisted reading
时间窗: 1 month after collection of data
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis
Per-lesion detection sensitivity unassisted vs CAD assisted reading
时间窗: 1 month after collection of data
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included
次要结局
- Comparison of reading time between unassisted vs CAD assisted reading(1 month after collection of data)
研究者
Alberto Traverso
PhD
Candiolo Cancer Institute - IRCCS