NCT07342374

Repositioning the Bolus Tracking ROI to the Superior Vena Cava in CTPA Facilitates Contrast Volume Reduction

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hospital Queen Elizabeth, Malaysia · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Artery Embolism
• Pulmonary Embolism (PE)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optimized CTPA Protocol	CTPA scans are performed on a 128-slice CT scanner using the bolus tracking technique. Non-ionic contrast medium (370 mgI/ml) is administered at a rate of 4 ml/s, followed by a 20 ml saline flush. The diagnostic scan is automatically triggered when enhancement in the monitoring region of interest (ROI) reaches a threshold of 100 HU, with a fixed transit delay time (TDT) of 5 seconds.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Malaysia