Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Sensitivity
研究概览
简要总结
Venous phase spectral or dual energy (DE) chest computed tomography (CT) in patients with suspected pulmonary embolism (PE) compared to standard computed tomography pulmonary angiography (CTPA): sensitivity, evaluation of iodine mapping and incidental findings.
详细描述
Background/rationale: DE CTPA provides additional anatomical and functional information in the investigation of PE, especially in regards of iodine uptake in pulmonary vasculature and lung parenchyma. Postprocessing techniques improve visualisation of low concentrations of iodine contrast media.This has shown potential in reducing the amount of contrast media, salvaging scans with suboptimal contrast enhancement and for improving visualisation of incidental pulmonary embolisms in portal venous chest CT scans. Other significant DE postprocessing techniques include the substraction of iodine, creating virtual non-contrast images in addition to the dual energy. This technique has proven useful in evaluation of different thoracic and abdominal parenchymal lesions.
Objective: To evaluate sensitivity of chest DECT in portal venous phase in the diagnosis of PE compared to standard care DE CTPA. Furthermore, the prevalence and management of incidental findings will be evaluated.
Design: Patients enrolled in this study will undergo a venous phase chest DE CT in addition to standard care DE CTPA. The two scans will be performed consecutively using the same contrast media bolus. Standard DE reconstructions of all scans will be obtained for radiological evaluation and reporting in regards of suspected PE.
Both scans with standard DE reconstructions will be available for clinical evaluation and patient care in the standard care AGFA PACS system. Radiological reading and reporting will be performed as usual in the clinical setting.
For research purposes, additional post-processing procedures may be performed by the readers in Philips IntelliSpace Portal or Siemens Syngo.via depending on the scanner applied. The standard CTPA will be interpreted by a thoracic radiologist and used as reference. The corresponding portal venous chest CT will be interpreted individually by two other certified radiologists in order to avoid recall bias. In case of disagreement in the venous chest CT, an independent radiologist not elsewhere involved will be consulted. If a PE detected on the portal venous scan is not detected on the reference CTPA, the reference reader will re-evaluate the CTPA.
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected for pulmonary embolism undergoing a computed tomography pulmonary angiography
- •Minimum age 50 years
排除标准
- •Temporarily or permanently incompetent patient not able to give informed consent
- •No informed consent obtained for other reasons
- •Allergic to iodine based contrast media
- •Impaired renal function
- •Patients with thyreotoxicosis
- •Non-diagnostic quality of computed tomography images
结局指标
主要结局
Sensitivity
时间窗: through study completion, approx. of 1 year
Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificity
时间窗: through study completion, approx. 1 year
Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
次要结局
- Incidental findings(through study completion, approx. of 1 year)
- Sensitivity(through study completion, approx. of 1 year)
- Iodine mapping(through study completion, approx. of 1 year)
- Specificity(through study completion, approx. of 1 year)
研究者
Yecatarina Zincuk Rohde, MD
MD
Copenhagen University Hospital at Herlev
