Non-Contrast 4DCT to Detect Pulmonary Thromboembolic Events

NCT03183063 | Completed Results FDA Device

• 1 other identifier: 2017-018
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

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

  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.

  1 hour

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

  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).

  48 hours

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

  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).

  48 hours

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Measure and Correlate the Airway Pressure Variance of RIBMC Images

  1 hour

Study Arms (3)

4DCT and SPECT/CT

EXPERIMENTAL

Anticipated 15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed for objectives 1, 4 and 5.

Device: 4DCT and SPECT/CT

4DCT with BiPAP and SPECT/CT

EXPERIMENTAL

Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Results in these patients will be analyzed for objective 6 only.

Device: 4DCT with BiPAP and SPECT/CT

4DCT with CTA in suspected PE

EXPERIMENTAL

Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for objectives 2 and 3.

Device: 4DCT with CTA in suspected PE

Interventions

4DCT and SPECT/CT DEVICE

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

4DCT and SPECT/CT

4DCT with BiPAP and SPECT/CT DEVICE

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

4DCT with BiPAP and SPECT/CT

4DCT with CTA in suspected PE DEVICE

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

4DCT with CTA in suspected PE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Guerrero: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Links

• Abstract on 4DCT ventilation imaging

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Single Photon Emission Computed Tomography Computed Tomography; Continuous Positive Airway Pressure; Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Joanne Gondert
• Organization: Beaumont Health

joanne.gondert@beaumont.org

248 551-0439

Study Officials

• Thomas Guerrero, MD, PhD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair Translational Research, Radiation Oncology

Model Details: Patients will be imaged with SPECT/CT and 4DCT to compare perfusion with the respiratory induced blood mass changed (RIBMC) defect. Each patient will have both imaging studies performed on the same day. 15 subjects will be enrolled into Cohort 1 and will receive SPECT/CT and 4DCT imaging as described. After those are enrolled another 5 subjects will be enrolled into Cohort 2 and will receive SPECT/CT and 4DCT imaging as previously described with the first 4DCT being obtained with normal breathing and the second scan being obtained with positive pressure breathing via BiPAP. Cohort 3 will enroll 124 participants with clinical suspicion of PE, who will be or have had CTA imaging. 4DCT imaging will be performed for these study participants.

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: April 12, 2017
• Primary Completion: April 23, 2019
• Study Completion: April 24, 2019
• Last Updated: June 5, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)