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Optimising Bolus Tracking Technique by Repositioning the Region of Interest (ROI) at the Superior Vena Cava and Reducing Contrast Media Volume in Computed Tomography Pulmonary Angiography (CTPA)
This randomized controlled trial evaluates a protocol optimization for Computed Tomography Pulmonary Angiography (CTPA). The study investigates the impact of repositioning the bolus-tracking region-of-interest (ROI) from the standard pulmonary trunk (PT) to the superior vena cava (SVC). The goal is to compensate for the CT scanner's inherent transit delay time (TDT) to better align the scan with the peak arterial phase. By optimizing this timing, the study assesses whether contrast media volume can be safely reduced by 40% (from 50 ml to 30 ml) while maintaining diagnostic image quality and preventing venous contamination.
Background and Rationale: Computed Tomography Pulmonary Angiography (CTPA) is the gold standard for diagnosing pulmonary embolism (PE). However, standard bolus tracking (BT) protocols that place the monitoring region-of-interest (ROI) on the main pulmonary trunk (PT) often face challenges due to the system's inherent Transit Delay Time (TDT). This delay, typically 5 seconds, can cause the diagnostic scan window to overlap with the venous phase, leading to suboptimal arterial opacification and venous contamination. This study proposes repositioning the monitoring ROI upstream to the superior vena cava (SVC) to utilize the TDT as transit time for the bolus, thereby aligning the scan window with the peak arterial phase. Study Objectives: The primary objective is to evaluate the effect of SVC ROI repositioning on diagnostic image quality while investigating the feasibility of reducing contrast media (CM) volume by 40% (from 50 ml to 30 ml). Methodology: This is a single-center, prospective, randomized controlled trial involving 72 adult patients. Participants are randomized into four protocol groups: Group A (Control): ROI at PT, 50 ml contrast media. Group B: ROI at PT, 30 ml contrast media. Group C: ROI at SVC, 50 ml contrast media. Group D: ROI at SVC, 30 ml contrast media. Protocol Details: * Contrast Administration: Non-ionic contrast medium (370 mgI/ml) is injected at a rate of 4 ml/s, followed by a 20 ml saline flush. * Bolus Tracking: An elliptical ROI is placed either on the PT (above the carina) or SVC depending on the group assignment. * Triggering: The diagnostic scan is automatically initiated when enhancement reaches a threshold of 100 HU. The TDT is set to a fixed 5 seconds. * Assessment: Diagnostic quality is assessed quantitatively by calculating arterial-venous enhancement differences (HU) and qualitatively via a 5-point Likert scale by three blinded radiologists.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Start Date
February 1, 2023
Primary Completion Date
December 16, 2024
Completion Date
December 16, 2024
Last Updated
January 15, 2026
72
ACTUAL participants
Optimized CTPA Protocol
DIAGNOSTIC_TEST
Lead Sponsor
Hospital Queen Elizabeth, Malaysia
Collaborators
NCT06946732
NCT06583616
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07107347