Deep-Learning Image Reconstruction in CCTA

Study Overview
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Brief Summary
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Cardiac CT allows the assessment of the heart and of the coronary arteries by use of ionising radiation. Although radiation exposure was significantly reduced in recent years, further decrease in radiation exposure is limited by increased image noise and deterioration in image quality. Recent evidence suggests that further technological refinements with artificial intelligence allows improved post-processing of images with reduction of image noise. The present study aims at assessing the potential of a deep-learning image reconstruction algorithm in a clinical setting. Specifically, after a standard clinical scan, patients are scanned with lower radiation exposure and reconstructed with the DLIR algorithm. This interventional scan is then compared to the standard clinical scan.

Official Title
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Usefulness of Deep-Learning Image Reconstruction for Cardiac Computed Tomography Angiography - a Prospective, Non-randomized Observational Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: TrueFidelity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for cardiac CT angiography Age ≥ 18 years Written informed consent Exclusion Criteria: Pregnancy or breast-feeding Enrollment of the investigator, his/her family members, employees and other dependent persons Renal insufficiency (GFR below 35 mL/min/1.73 m²)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal-dose versus Low-dose<br>The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes. | Device: TrueFidelity<br>* TrueFidelity (Deep Learning Image Reconstruction, DLIR) software by GE Healthcare. The medical device in question is a novel reconstruction algorithm for raw CT data which is based on artificial intelligence approaches, namely deep-learning iterative reconstruction (DLIR). This DLIR algorithm will be installed on the console of the CT Revolution scanning device, which is in routine clinical use for cardiac CT scans at the Department of Nuclear Medicine at the University Hospital Zurich. Purpose of this installation is the assessment of the performance of the DLIR algorithm during a limited time span of six weeks. The algorithm will be CE-marked at the time of installation and use (statement by GE Healthcare provided separately). Its intended use is the reconstruction of CT datasets. Of note, the novel DLIR algorithm will not substitute any clinical routine procedures currently in use. That is, diagnosis will still be made using the standard reconstruction algorithms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Image Quality | Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal Intensity | Signal intensity as average hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention | Day 1 | 
| Image Noise | Image noise as standard deviation of hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention | Day 1 | 
| Signal-to-noise Ratio | Signal-to-noise ratio | Day 1 | 
| Dose-length Products | Comparison of dose-length products | Day 1 | 
| Plaque Volumes | Quantitative analysis of coronary artery plaque volumes | Day 1 |