Deep-Learning Image Reconstruction in CCTA

University of Zurich (UZH)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: TrueFidelity

Study type: Interventional

Funder types: Other

Identifiers

NCT03980470

USZ-2019-00533

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Normal-dose versus Low-dose

Other group

Description:

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.

Treatment:

Device: TrueFidelity