Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Endpoints: Global Fiducial Registration Error (FRE) of real-time US and fused CT images, Target Registration Error (TRE) and distance between lesional epicenters of real-time US and fused CT images.
研究概览
简要总结
Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.
详细描述
Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.
Optimize image fusion algorithms for use in goal. Develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Focal lesion involving the liver or kidney bases on CT or MRI Imaging
- •Liver lesion size >5 mm and <5 cm in diameter or renal lesion size is >5 mm and <4 cm in diameter
- •Age >18 years old
- •Patient has provided written informed consent
排除标准
- •Patient with cardiac pacemaker or defibrillator
- •Pregnant or lactating woman
- •Patient with severe IV contrast allergy (previous reaction to IV contrast not mitigated by appropriate premedication)
- •Patient unable to give informed consent
结局指标
主要结局
Primary Endpoints: Global Fiducial Registration Error (FRE) of real-time US and fused CT images, Target Registration Error (TRE) and distance between lesional epicenters of real-time US and fused CT images.
时间窗: 2 years
次要结局
- Secondary Endpoint: Number of coregistration attempts to realize separation of lesional epicenters of real-time US and fused CT images of ≤2 cm and the number of attempts to realize a separation of ≤0.3 cm.(2 years)
研究者
Matthew R. Callstrom
Study Prinicple Investigator
Mayo Clinic