N/A
N=139
Non-Contrast 4DCT to Detect Pulmonary Thromboembolic Events
Pulmonary Thromboembolisms · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT03183063 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Correlation of 4DCT Identified Perfusion With SPECT/CT Identified Perfusion — 0.45 Spearman correlation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4DCT and SPECT/CT (Device); 4DCT with BiPAP and SPECT/CT (Device); 4DCT with CTA in suspected PE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Guerrero
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of 4DCT Identified Perfusion With SPECT/CT Identified Perfusion |
0.45 | — |
| PRIMARY Count of Participants With True Positive Detection of PE Using Contrast-free 4DCT Functional Imaging and SPECT/CT (Sensitivity) |
40 | — |
| PRIMARY Count of Participants With True Negative Detection of PE Using Contrast-free 4DCT Functional Imaging (Specificity) |
57 | — |
| SECONDARY Measure and Correlate the 4DCT Re-imaging Variance in Radiographic Tidal Volume of RIBMC Images |
14.84 | — |
| SECONDARY Measure and Correlate the 4DCT Re-imaging Variance in Parenchymal Lung Mass of RIBMC Images |
18.23 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03183063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.