Clinical Trial: The Paediatric Virtual Autopsy Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Zurich

Current Primary Outcome: Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions [ Time Frame: 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.


Original Primary Outcome: Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions [ Time Frame: 4 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.


Current Secondary Outcome:

  • Clinical indication [ Time Frame: 8 weeks ]
    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
  • MR Protocol [ Time Frame: 8 weeks ]
    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
  • Change in the ante-mortem diagnosis [ Time Frame: 8 weeks ]
    The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.


Original Secondary Outcome:

  • Clinical indication [ Time Frame: 4 weeks ]
    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
  • MR Protocol [ Time Frame: 4 weeks ]
    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
  • Change in the ante-mortem diagnosis [ Time Frame: 4 weeks ]
    The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.


Information By: University of Zurich

Dates:
Date Received: June 17, 2013
Date Started: January 2014
Date Completion: June 2018
Last Updated: May 2, 2017
Last Verified: May 2017