Non-Contrast 4DCT to Detect Pulmonary Thromboembolic Events

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.

Conditions

• Pulmonary Thromboembolisms
• Pulmonary Embolism

Interventions

DEVICE

4DCT and SPECT/CT

Each patient will receive two 4DCT followed by SPECT/CT.

DEVICE

4DCT with BiPAP and SPECT/CT

Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT

DEVICE

4DCT with CTA in suspected PE

Each patient will receive 4DCT before or after CTA for suspected PE

Sponsors & Collaborators

• Thomas Guerrero

  lead OTHER

Principal Investigators

• Thomas Guerrero, MD, PhD · Beaumont Health

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-12

Primary Completion

2019-04-23

Completion

2019-04-24

FDA Device

Yes

Countries

• United States

Study Locations