NCT07317479尚未招募不适用
Clinical Study for P-MAR Metal Artifact Reduction Algorithm 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
- 120
- 主要终点
- The extent of metal artifacts and diagnostic confidence of P-MAR
研究概览
简要总结
The purpose of this clinical study is to evaluate the performance of the P-MAR metal artifact reduction algorithm for CT imaging (with metal present) of adult patients (>18 years old).
The study has two objectives:
- To evaluate the extent of metal artifacts and diagnostic confidence, and overall image quality (independent of metal artifacts) of P-MAR compared to images without metal correction, and compared to O-MAR, for CT images (with metal present) of adult patients (>18 years old).
- To demonstrate non-inferiority of P-MAR compared to images without metal correction for the relevant metal groups.
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 Years 至 —（Adult, Older 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.
- •Subject age: Above 18 years old.
- •Scans with metal present (orthopedic implants/joint prothesis, dental filling/implants, spine screw(s), pacemaker, coils, radiotherapy beads, surgical clips/staples, metal objects either outside the body or near air, etc.)
排除标准
- •Subject age: 18 years old and below.
- •CT scans with no metal present.
- •CT scans with metal with motion artifacts.
- •Surview or Locator/Tracker.
- •CT scans performed utilizing respiratory gating (e.g., "pulmo gating").
- •CT scans performed utilizing cardiac gating.
- •CT Perfusion scans.
- •CCT scans.
- •Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
- •Scans that are not completed due to technical difficulties.
结局指标
主要结局
The extent of metal artifacts and diagnostic confidence of P-MAR
时间窗: Reading session at 4 months
The extent of metal artifacts and diagnostic confidence of P-MAR reconstructions is at least as good as (non-inferior to) images without metal correction, for CT images (with metal present) of adult patients (\>18 years old).
次要结局
未报告次要终点
研究者
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