跳至主要内容
临床试验/NCT01888380
NCT01888380已完成不适用

Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children

University of Zurich4 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年1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
入组人数
105
试验地点
4
主要终点
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions

研究概览

简要总结

In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death. A major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. The objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy, with conventional autopsy procedures in a paediatric population.

Foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the University of Zurich will be eligible for recruitment. All bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators will be blinded to the results of conventional autopsy. After cross-sectional imaging, CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot) allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard.

This interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Stillborn infants ≥ 16 0/7 weeks of gestational age (GA)
  • •Live born infants ≥ 16 0/7 weeks GA until adolescents up to 16 years of age, who died of natural- and non-natural cause (trauma, homicide, suicide and intoxication).

排除标准

  • •Deceased infants who are donors of organs
  • •Lack of parental consent

研究组 & 干预措施

Newborns

Experimental
  • who died of natural- and non-natural cause
  • intervention: minimally invasive, virtual autopsy

干预措施: Conventional autopsy (Procedure)

Newborns

Experimental
  • who died of natural- and non-natural cause
  • intervention: minimally invasive, virtual autopsy

干预措施: Minimally invasive, virtual autopsy (Procedure)

Foetuses

Experimental
  • still birth and termination of pregnancies
  • intervention: minimally invasive, virtual autopsy

干预措施: Minimally invasive, virtual autopsy (Procedure)

Foetuses

Experimental
  • still birth and termination of pregnancies
  • intervention: minimally invasive, virtual autopsy

干预措施: Conventional autopsy (Procedure)

Children and adolescents

Experimental
  • who died of natural- and non-natural cause
  • intervention: minimally invasive, virtual autopsy

干预措施: Minimally invasive, virtual autopsy (Procedure)

Children and adolescents

Experimental
  • who died of natural- and non-natural cause
  • intervention: minimally invasive, virtual autopsy

干预措施: Conventional autopsy (Procedure)

结局指标

主要结局

Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions

时间窗: 8 weeks

The diagnoses established in both ways by the two independent teams will be compared, the autopsy results being the gold standard. The primary outcome will be the percentage of cases for which virtual autopsy correctly identifies the diagnostic category.

次要结局

  • MR Protocol(8 weeks)
  • Change in the ante-mortem diagnosis(8 weeks)
  • Clinical indication(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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