On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 958
- 试验地点
- 2
- 主要终点
- Parameters of Objective Image Quality
研究概览
简要总结
CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.
The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
no masking required
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
- •patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
- •patient is at least 18 years of age AND
- •patient (is able to give informed consent and) has given informed consent.
排除标准
- •high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
- •known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
结局指标
主要结局
Parameters of Objective Image Quality
时间窗: 1 year
Measured as signal, image noise and modulation transfer function equivalent parameters
Parameters of Radiation Dose
时间窗: 1 year
measured as x-ray tube parameters such as dose length product (DLP)
次要结局
- Subjective Image Quality Evaluation (entire cohort and for individual disease groups)(1 year)