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临床试验/NCT04859478
NCT04859478Unknown不适用

Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.

Copenhagen University Hospital at Herlev4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年1月1日最近更新:
适应症

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

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

发起方
Copenhagen University Hospital at Herlev
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yecatarina Zincuk Rohde, MD

MD

Copenhagen University Hospital at Herlev

研究点 (4)

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