Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 2
- 主要终点
- Presence of perfusion defects as reference standard
研究概览
简要总结
Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.
详细描述
Rationale: Iodine mapping of the lung using subtraction imaging in addition to standard computed tomography pulmonary angiography (CTPA) may improve the evaluation of pulmonary embolism (PE) in the same manner as the addition of dual energy computed tomography (DECT) to CTPA.
Objective: To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that subtracts a low radiation dose unenhanced CT from mono-energetic CTPA (subtraction) Study design: A maximum of 375 patients will undergo a standard CTPA with DECT according to local clinical guidelines, to have 30 patients with pulmonary embolism. For the purposes of this study, patients will undergo an additional unenhanced, low-radiation dose chest CT. Standard reconstructions of all scans and DECT iodine maps will be obtained for clinical reporting and subsequent treatment decisions, according to standard clinical routine. For research purposes, selected mono-energetic images will be post-processed using a novel subtraction algorithm to create iodine maps of the lungs. The iodine maps based on the subtraction algorithm will not be used for clinical management, only the additional unenhanced scan will be used in clinical management.
Study population: Patients presenting with a clinical indication for pulmonary CT angiography because of suspected pulmonary embolism. Only adult patients (≥ 35 years) who are able to provide informed consent will be enrolled.
Main study parameters/endpoints:
Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 35 years or older and able to provide informed consent
- •Clinically requested CTPA because of suspected pulmonary embolism
- •Available history and physical examination.
排除标准
- •Pregnancy
- •Hemodynamic instability
- •Uncooperative patients.
- •Contra-indication to intravenous iodine administration.
- •Inability to position the arms above the shoulders
研究组 & 干预措施
Patients
Each patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques.
干预措施: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography (Device)
结局指标
主要结局
Presence of perfusion defects as reference standard
时间窗: 1.5 year
After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard.
次要结局
- 30-day all cause mortality and PE-associated mortality(Through study completion, an average of three months)
- Radiation dose(Through study completion, an average of 2 months)
- Clinical diagnosis of Pulmonary embolism: after 6 months follow-up(Through study completion, after the first inclusion, the patients are followed for half a year.)
- 6 months all cause mortality and PE-associated mortality(Through study completion, an average of three months)