X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI)
研究概览
简要总结
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.
In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .
The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.
The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children (< 18 years of age)
- •with a pectus deformity
- •recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available.
排除标准
- 未提供
研究组 & 干预措施
Standard protocol using chest CT
干预措施: chest CT (Device)
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
干预措施: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device (Device)
结局指标
主要结局
To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI)
时间窗: At 12 month
次要结局
- To compare the Haller Index measured with CT and the HI measured with MRI(At 12 month)
- To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner(At 12 month)