Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography.

Recruiting

• Conditions: Pulmonary embolism; Arteria pulmonalis embolism; 10037454; 10014523

• Registration Number: NL-OMON43477
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 375

Inclusion Criteria

- patients 35 years or older and able to provide informed consent
- clinically requested CTPA because of suspected pulmonary embolism
- available history and physical examination

Exclusion Criteria

- pregnancy
- hemodynamic instability
- uncooperative patients
- contra-indication to intravenous iodine administration.
- inability to position the arms above the shoulders

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint of the study is presence of perfusion as established by an expert<br /><br>panel with access to all imaging information (including CTPA, subtraction and<br /><br>DECT) and clinical follow-up. Accuracy of DECT and subtraction is established<br /><br>by observers who are blinded to CTPA and clinical data. Presence of iodine<br /><br>density differences in perfusion defects is measured using region of interest<br /><br>(ROI) measurements.<br /><br>Images will be evaluated for objective and subjective image quality. Patient<br /><br>characteristics, radiation dose, clinical diagnosis, treatment decisions and<br /><br>patient outcome (all cause - and PE related mortality) will be recorded. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>