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临床试验/NCT03183063
NCT03183063已完成不适用

A Novel Method to Detect Pulmonary Thromboembolic Events With Non-Contrast 4DCT

Thomas Guerrero2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2017年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
2
主要终点
Count of Participants With True Positive Detection of PE Using Contrast-free 4DCT Functional Imaging and SPECT/CT (Sensitivity)

研究概览

简要总结

Deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein, typically in the lower extremities. Pulmonary embolism (PE) occurs when a DVT clot (or fragment) breaks free and travels through the heart to the pulmonary arteries (having to do with the lungs) and lodges in an artery causing a partial or complete blockage. PE is difficult to diagnose due to the non-specific signs and symptoms patients have with this condition such as a cough, shortness of breath, increased heart rate, blood tinged sputum, low oxygen levels.

The standard test to diagnose PE is the Pulmonary Computed Tomography Angiogram (CTA). This can be prohibitive with some patients due to the amount of radiation exposure as well as the complications associated with the need to use intravenous (IV) contrast. In this study the investigators are looking at an alternative method of diagnosing PE's in the Emergency Department where the investigators look at the breathing and blood flow to the lungs thru respiratory gated non-contrast CT (commonly called 4DCT).

The investigators hypothesize that respiratory induced blood mass change in the lungs will allow the identification of under-perfused lung regions.

Cohort 1: An anticipated15 participants will be enrolled with a diagnosis of PE by CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Respiratory induced blood mass change images will be issued from the 4DCT and compared to the SPECT/CT images.

Cohort 2: An anticipated 5 participants will be enrolled under the same criteria and study procedures as Cohort 1. The participants in Cohort 2 will have the addition of Bilevel Positive Airway Pressure (BiPAP) during the 4DCT imaging. This cohort will be used to compare the effect of airway pressure on 4DCT image.

Cohort 3: An anticipated 124 participants will be enrolled. Study procedure will be 4DCT only. Participants must be having or have had a CTA to rule in/out PE. This cohort of the study will be using 4DCT to compare negative CTA to positive CTA findings.

详细描述

The standard test to diagnose PE is the Pulmonary Computed Tomography Angiogram (CTA). This can be prohibitive with some patients due to the amount of radiation exposure as well as the complications associated with the need to use intravenous (IV) contrast. CTA can detect acute PE with a sensitivity of 99 percent and specificity of 95 percent when combined with CT venography. In patients not medically eligible for CTA, the other option for diagnosis is a ventilation-perfusion (V/Q) single photon emission computed tomography (SPECT) scan. Though this is often prohibitive due to transport to Nuclear Medicine dept., prolonged test time, no test during off hours, etc. In this study the investigators are looking at an alternative method of diagnosing PE's in the Emergency Department where the investigators look at ventilation and perfusion images thru respiratory gated non-contrast CT (commonly called 4DCT).

Technetium-99 m macroaggregated albumin (99mTc-MAA) imaged with single photon emission computed tomography (SPECT) is considered the standard method for the quantitative determination of pulmonary perfusion. Magnetic resonance imaging (MRI) with contrast agents have been utilized experimentally to image the pulmonary vasculature and tissue perfusion. Quantification of SPECT images requires correction of the acquired data for attenuation and attenuation correction, which has lead to the development of SPECT/CT scanners. The low-dose CT can be utilized to evaluate the lung airway architecture, lung parenchyma, and pleural space in conjunction with the registered perfusion images rivaling CTA in sensitivity and specificity.

In a study comparing CT attenuation with SPECT perfusion defects, patients were found to have hypo-attenuated pulmonary regions corresponding to regions with decreased perfusion in 57 percent of acute pulmonary emboli and 88 percent of chronic emboli cases. In the same study, hyper-attenuated regions were found to correspond to regions with hyperperfusion. A method to measure pulmonary perfusion based on subtraction digital fluoroscopy without contrast has been reported. In that study, subtraction images were generated between chest projection images at systole and diastole generating an image representing the perfusion difference. These perfusion projection images were correlate with 99mTc-MAA scintigraphy. Thus, changes in the amount and distribution of pulmonary perfusion throughout the respiratory cycle can be expected and these changes may be apparent on dynamic CT.

Simon described a technique to calculate the change in fractional content of air within pulmonary tissue between anatomically matched CT regions based on a simple model that assumes the density changes were solely due to air content. The investigators successfully applied that model to inhale and exhale breath-hold CT image pairs as well as 4DCT images to create ventilation images. However, the amount of blood in the thorax and lungs varies with the respiratory cycle, thus violating the assumption of this model. The investigators found a cyclic variation in the apparent weight of the lung on 4DCT and others have reported respiratory induced variations in pulmonary perfusion of the lung on MRI. The pulmonary density changes found on 4DCT thus result from both changes in air and blood content.

4DCT derived ventilation images can also be inferred from the respiratory motion induced local tissue volume changes independent of the 4DCT density values. The Jacobian determinant of the deformation field, calculated from the result of images depicting different respiratory phases of the lungs, is used to estimate the local volume changes or ventilation. There is a discrepancy between the density based and the Jacobian based ventilation images suggesting a method to extract respiratory induced blood mass change from 4DCT images. The investigators hypothesize the respiratory induced blood mass changed (RIBMC) will only occur within perfused lung regions. Each image set will contain information representing the density change resulting from both ventilation and RIBMC. Extracting both ventilation and perfusion-like image from the 4DCT image intensities, referred to as Hounsfield Units (HU) is our goal.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

入选标准

  • Patients with segmental or lobar pulmonary emboli on CTA identified within the past 48 hours
  • May have initiated anticoagulation therapy
  • Patients must sign informed consent to enter this study
  • Documented not pregnant if child-bearing age woman

排除标准

  • Patients unable to tolerate two 15-minute (4DCT) and one 30-minute imaging sessions (SPECT/CT) in the same day
  • Unable to sign informed consent due to cognitive impairment or health status
  • Patients who are unstable from a respiratory status requiring ICU care
  • Patients who receive tissue plasminogen activator
  • Patients who are <18 years old

结局指标

主要结局

Count of Participants With True Positive Detection of PE Using Contrast-free 4DCT Functional Imaging and SPECT/CT (Sensitivity)

时间窗: 48 hours

For each case, an automated PE detection algorithm will determine if functional deficits exist within CT-V and RIBMC. The patient will be classified as PE positive if the algorithm confirms the presence of two or more mismatched segmental or subsegmental defects between CT-V and RIBMC images. This CT-functional imaging (CT-FI) binary classification indicator will be acquired for each patient and compared to the result from the standard acquired CTA. Data will be reported as the count of participants determined to have PE by both imaging modalities (true positives, specificity).

Correlation of 4DCT Identified Perfusion With SPECT/CT Identified Perfusion

时间窗: 1 hour

A custom automated PE detection algorithm will delineate hypo-perfused regions of interest (ROIs) on SPECT perfusion and ROIs on respiratory induced blood mass change (RIBMC) via SPECT/CT. Spatial overlap between hypo-perfused ROIs on SPECT perfusion (standard) and ROIs on RIBMC will be assessed using Dice similarity coefficient (DSC). Spearman correlation will be reported.

Count of Participants With True Negative Detection of PE Using Contrast-free 4DCT Functional Imaging (Specificity)

时间窗: 48 hours

For each case, an automated PE detection algorithm will determine if functional deficits exist within CT-V and RIBMC. The patient will be classified as PE negative if the algorithm cannot confirm the presence of two or more mismatched segmental or subsegmental defects between CT-V and RIBMC images. This CT-functional imaging (CT-FI) binary classification indicator will be acquired for each patient and compared to the result from the standard acquired CTA. Data will be reported as count of participants determined not to have PE by both imaging modalities (true negatives, sensitivity).

次要结局

  • Measure and Correlate the 4DCT Re-imaging Variance in Radiographic Tidal Volume of RIBMC Images(1 hour)
  • Measure and Correlate the 4DCT Re-imaging Variance in Parenchymal Lung Mass of RIBMC Images(1 hour)

研究者

发起方
Thomas Guerrero
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Thomas Guerrero

Vice Chair Translational Research, Radiation Oncology

William Beaumont Hospitals

研究点 (2)

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