Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
研究概览
简要总结
A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging platform for lung lesion detection.
详细描述
A feasibility study is proposed to investigate the imaging characteristics captured by a Single Exposure Dual-Energy Subtraction digital radiography with KA Imaging's Multi-energy detector.
The acquisition of Dual-Energy Subtraction radiography will consist of using the Multi-Energy detector integrated into the X-ray system in Grand River Hospital. Patient will receive a Multi-Energy Chest radiography exam on the same day as their routine chest CT exam. Each Multi-Energy radiography exam will consist of one Chest PA image and one Chest LAT image. Duration of each procedure is 60 minutes. The Multi-Energy Detector will generate a General Radiography Image and Dual-Energy Subtracted Images.
Visualization of lung lesions by Multi-Energy detector will be compared to corresponding CT exam and general radiography results. Imaging data will be evaluated qualitatively by radiologists on data collection form to describe the findings on the images. Further comparison between general radiography, Dual-Energy Subtraction radiography and CT will be analyzed to determine the differences of imaging characteristics such as description of image quality and visibility of relevant anatomical structures and anomalies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 and older.
- •Patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule
- •Subject is able to provide informed consent
- •Study participant is scheduled to have a chest CT exam as part of their routine care.
- •Study participant is able to stand and be still during the exams.
排除标准
- •Not able or willing to provide Informed Consent, or consent is withdrawn.
- •Study participant is pregnant
- •Study participant is unable to perform standard radiography exam and CT exam
结局指标
主要结局
Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
时间窗: 3 months
Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions, as determined. Expert readers will qualitatively evaluate the imaging differences (e.g. motion artifacts, technical defects, ease of anomalies identification, etc) with an evaluation form with a questionnaire grading system (i.e. 1 (severe defect), 2 (moderate defect) to 5 (no defect)).
次要结局
- Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.(3 months)