跳至主要内容
临床试验/NCT01743703
NCT01743703已完成不适用

Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
199
试验地点
1
主要终点
positive predictive value of MRI for detecting skeletal injuries

研究概览

简要总结

The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.

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
— 至 3 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

排除标准

  • •Sub-dural hematoma of accidental origin or skeletal injuries of accidental
  • •Origin or known origin of lesions.
  • •Subject already included in the study

研究组 & 干预措施

whole body MRI

Other

diagnostic whole body MRI, and skeletal imaging following guidelines (whole body radiographic and scintigraphic screening)

干预措施: diagnostic whole body MRI (Other)

结局指标

主要结局

positive predictive value of MRI for detecting skeletal injuries

时间窗: one week

standard skeletal imaging is used as reference

sensibility of MRI for detecting skeletal injuries

时间窗: one week

standard skeletal imaging is used as reference

次要结局

  • predictive positive value of MRI for detecting children with skeletal injuries(one week)
  • specificity of MRI for detecting children with skeletal injuries(one week)
  • sensibility of MRI for detecting children with skeletal injuries(one week)
  • predictive negative value of MRI for detecting children with skeletal injuries(one week)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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