Venous Phase Dual Energy CT in Patients Suspected for Pulmonary Embolism.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolus/Emboli; Thromboembolism, Pulmonary
• Intervention / Treatment: Diagnostic test: Dual energy / spectral portal venous chest computed tomography

Detailed Description

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.

Patient characteristics, clinical information, radiation dose, contrast media, clinical diagnosis, incidental findings and recommendations of further clinical management according to clinical guidelines will be recorded in a secure web-based database.

Study population: Patients aged ≥50 with suspected pulmonary embolism who are having performed a standard care CTPA.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yecatarina Zincuk Z Rohde, MD; Phone Number: +4560222733; Email: katjazincuk@hotmail.com
• Study Contact Backup: Name: Michael B Andersen, MD; Phone Number: 004531254343; Email: michael.brun.andersen@regionh.dk

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Recruiting
      • Copenhagen University Gentofte Hospital
      • Contact: Liva J Spindler, MD
  • Herlev
    • Copenhagen, Herlev, Denmark, 2400
      • Recruiting
      • Copenhagen University Hospital, Herlev Hospital
      • Contact: Louis L Plesner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients suspected for pulmonary embolism undergoing a computed tomography pulmonary angiography
• Minimum age 50 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: All eligible patients; All patients undergo the same CT protocol in addition to standard care.	Diagnostic test: Dual energy / spectral portal venous chest computed tomography; Each patient undergoes an additional dual energy / spectral chest CT in addition to standard care CTPA. The intervention is performed immediately after standard care CTPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA	through study completion, approx. of 1 year
Specificity	Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA	through study completion, approx. 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Lobe and segment based sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA	through study completion, approx. of 1 year
Specificity	Lobe and segment based specificicty of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA	through study completion, approx. of 1 year
Incidental findings	Evaluation and management of incidental findings in portal venous phase chest CT compared to standard care CTPA.	through study completion, approx. of 1 year
Iodine mapping	Comparison of perfusion defects on iodine mapping between portal venous chest CT and CTPA. Descriptive.	through study completion, approx. of 1 year

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Investigators: Principal Investigator: Yecatarina Z Rohde, MD, Copenhagen University Herlev Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (ACTUAL): April 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Imaging; Computed tomography; CT; Radiology; Diagnostic accuracy; Sensitivity; Dual energy; CTPA; Computed tomography pulmonary angiography; Spectral; Incidental findings; Iodine mapping
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: H-20035522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No