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| Name | Class |
|---|---|
| Universiti Sultan Zainal Abidin | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: PT-ROI, 50 ml (Control) | Active Comparator | Standard CTPA protocol using the bolus tracking technique with the monitoring region of interest (ROI) placed at the pulmonary trunk (PT) and 50 ml of contrast media. |
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| Group B: PT-ROI, 30 ml | Experimental | Modified CTPA protocol using the bolus tracking technique with the monitoring ROI at the pulmonary trunk (PT) and a reduced contrast volume of 30 ml. |
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| Group C: SVC-ROI, 50 ml | Experimental | Modified CTPA protocol using the bolus tracking technique with the monitoring ROI repositioned upstream to the superior vena cava (SVC) and 50 ml of contrast media. |
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| Group D: SVC-ROI, 30 ml | Experimental | Modified CTPA protocol using the bolus tracking technique with the monitoring ROI repositioned upstream to the superior vena cava (SVC) and a reduced contrast volume of 30 ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized CTPA Protocol | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Hounsfield Unit (HU) Attenuation Between Pulmonary Artery and Pulmonary Vein | This quantitative measurement assesses the degree of arterial opacification relative to venous contamination by calculating the difference in Hounsfield Units (HU). It is calculated by subtracting the mean HU value of the pulmonary vein from the mean HU value of the pulmonary artery at the same anatomical level. A larger positive difference indicates superior arterial enhancement with minimal venous contamination. | At the time of post-procedural image analysis (approximately 48 hours after CTPA scan completion). |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Image Quality Score using a 5-point Likert Scale | Qualitative assessment of CTPA images performed by three blinded senior radiologists using a 5-point Likert scale (1 = Unacceptable, 2 = Sub-optimal, 3 = Acceptable, 4 = Good, 5 = Excellent). The score evaluates overall arterial enhancement, presence of artifacts, and diagnostic adequacy. | Within 1 month following the CTPA scan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamarul Amin. bin Abdullah @ Abu Bakar., Assoc. Prof. Ts. Dr. | Universiti Sultan Zainal Abidin (UniSZA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Queen Elizabeth | Kota Kinabalu | Sabah | 88200 | Malaysia |
Individual participant data will be kept strictly confidential in accordance with the hospital's privacy policies and the informed consent agreement. To protect participant privacy, only aggregated results and statistical data will be reported in publications.
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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This study uses a four-arm parallel assignment to compare two primary factors: the anatomical location of the bolus-tracking region of interest (ROI) and the volume of contrast media administered. Participants are randomized into one of four distinct protocol groups (Groups A, B, C, or D) to evaluate image quality and opacification differences across the various combinations of ROI placement (Pulmonary Trunk vs. Superior Vena Cava) and contrast volume (50 ml vs. 30 ml).
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Three senior radiologists served as blinded outcomes assessors for this study. These assessors were blinded to all protocol details, including the anatomical location of the bolus-tracking region of interest (ROI) and the volume of contrast media administered for each participant. The CTPA images were anonymized and presented to the assessors in a randomized order to ensure objective qualitative evaluation of image quality using the 5-point Likert scale.
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |