The Paediatric Virtual Autopsy Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Stillbirth, Newborn Death, Sudden Infant Death

Intervention / Treatment
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* Procedure: Minimally invasive, virtual autopsy
* Procedure: Conventional autopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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). Exclusion criteria: Deceased infants who are donors of organs Lack of parental consent

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foetuses<br>still birth and termination of pregnancies intervention: minimally invasive, virtual autopsy | Procedure: Minimally invasive, virtual autopsy<br>* Post-mortem cross-sectional imaging with CT-guided biopsy<br>* Other names: Virtopsy;Procedure: Conventional autopsy<br> <br> * Other names: Postmortem;|
| Experimental: Newborns<br>who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy | Procedure: Minimally invasive, virtual autopsy<br>* Post-mortem cross-sectional imaging with CT-guided biopsy<br>* Other names: Virtopsy;Procedure: Conventional autopsy<br> <br> * Other names: Postmortem;|
| Experimental: Children and adolescents<br>who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy | Procedure: Minimally invasive, virtual autopsy<br>* Post-mortem cross-sectional imaging with CT-guided biopsy<br>* Other names: Virtopsy;Procedure: Conventional autopsy<br> <br> * Other names: Postmortem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions | 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. | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autopsy, Minimally invasive, Foetuses, Newborns, Children, Adolescents