Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Ultra low dose CT lung nodule detection sensibility
研究概览
简要总结
Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).
详细描述
An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose delivered with the two acquisitions is still lower than the french diagnostic reference level. Standard CT is interpreted and a report is sent to the referent physician as usual. Then the two acquisitions are read over time by two independent radiologists, blinded over judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating than a standard low dose CT, as a sensitive tool to detect lung nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
blinding evaluation of criteria
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
- •Patients referred for non enhanced chest CT for following indications :
- •lung nodule search or control
- •nodular abnormality on chest X ray
- •statement of COPD or emphysema
- •asbestos exposure
- •nodule localization before radio frequency ablation
- •assessment of disease extent of an extra thoracic cancer (in case of iodinated intravenous contrast agent contraindication)
- •statement before extrathoracic transplantation (in case of iodinated intravenous contrast agent contraindication)
- •Affiliated with the french social security
- •Who signed consent
排除标准
- •Inability to lie down and still during the examination
- •Inability to hold breath more than 5 seconds
- •Pneumonia in the last 3 months
- •Body mass index more than 35kg/m²
- •exclusion period of another interventionnal study
- •referred for articles L1121-5 to L1121-8 of french public health code
- •Pregnant or breastfeeding women
研究组 & 干预措施
Low dose chest CT
干预措施: Low dose chest CT (Device)
Ultra low dose chest CT
干预措施: Ultra low dose chest CT (Device)
结局指标
主要结局
Ultra low dose CT lung nodule detection sensibility
时间窗: 22 months
Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
次要结局
- Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT(22 months)
- Ultra low dose CT diagnostic performances of lung nodule detection(22 months)
- Ultra low dose CT inter-observer reproducibility(22 months)
- Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT(22 months)
- Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT(22 months)
- Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT(22 months)
- Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT(22 months)