Clinical Study for Precise Image for Pediatrics for Incisive CT and CT 5300 Systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale
研究概览
简要总结
The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm in pediatric patients (specifically, head and body CT imaging of patients from 18 months up to and including 18 years of age). Clinical data generated from this study is intended to support a proposed expansion of the intended population of Precise Image.
The study has two objectives:
- To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for:
- Head and body CT images of pediatric patients (from 18 months up to and including 18 years of age).
- To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.
详细描述
This is a retrospective, observational, multi-site, controlled, blinded, non-inferiority clinical investigation.
Precise Image is a reconstruction mode using a trained deep learning neural network to generate images with reduced noise and improved low contrast detectability at lower doses compared with standard FBP (filter back projection) reconstruction.
Pediatric subjects (from 18 months up to and including 18 years of age) scanned by the FDA-cleared Philips Incisive CT (K212441) or CT 5300 (K232491) systems.
The study will include reconstructed images of 168 CT scans in total. For each of the anatomies and resolutions, 42 scans will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
- •Subject age: From 18 months up to and including 18 years of age.
排除标准
- •Subject age: Below 18 months and above 18 years of age.
- •Scans that were acquired using generic 'Head' and 'Body' scan types (as Precise Image does not support generic 'Head' and 'Body' scan types).
- •Head scans (brain and sinus/facial/orbits) acquired with a kilovoltage peak (kVp) outside the range of 100-120 kVp (as Precise Image does not support kVp settings outside this range for these clinical scan types).
- •Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
- •Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
- •Scans that failed internal technical checks (e.g., corrupt files, failure to reconstruct).
结局指标
主要结局
Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale
时间窗: Reading session at 4 months
The image quality and diagnostic acceptability of Precise Image reconstructions are non-inferior to iDose4 reconstructions for head and body CT images of pediatric patients (from 18 months up to and including 18 years of age). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.
次要结局
未报告次要终点