Usefulness of Deep-Learning Image Reconstruction for Cardiac Computed Tomography Angiography - a Prospective, Non-randomized Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subjective Image Quality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for cardiac CT angiography
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •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)
研究组 & 干预措施
Normal-dose versus Low-dose
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.
干预措施: TrueFidelity (Device)
结局指标
主要结局
Subjective Image Quality
时间窗: Day 1
Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent)
次要结局
- Signal-to-noise Ratio(Day 1)
- Signal Intensity(Day 1)
- Dose-length Products(Day 1)
- Image Noise(Day 1)
- Plaque Volumes(Day 1)
研究者
Ronny R Buechel, MD
PD Dr. med. Ronny R. Buechel
University of Zurich