NCT01888380

The Paediatric Virtual Autopsy Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stillbirth
• Newborn Death
• Sudden Infant Death

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive, virtual autopsy	Post-mortem cross-sectional imaging with CT-guided biopsy
PROCEDURE	Conventional autopsy

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-07-31
• Completion: 2018-08-31
• First posted: 2013-06-27
• Last updated: 2021-01-11

Locations

4 sites across 1 country: Switzerland