The Paediatric Virtual Autopsy Trial

Not Applicable

Completed

• Conditions: Sudden Infant Death; Stillbirth; Newborn Death
• Interventions: Procedure: Minimally invasive, virtual autopsy; Procedure: Conventional autopsy

• Registration Number: NCT01888380
• Lead Sponsor: University of Zurich

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-27
• Study Start: 2014-01-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31
• Status Verified: 2020-03
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Children and adolescents	Minimally invasive, virtual autopsy	* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy
Newborns	Minimally invasive, virtual autopsy	* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy
Foetuses	Conventional autopsy	* still birth and termination of pregnancies * intervention: minimally invasive, virtual autopsy
Foetuses	Minimally invasive, virtual autopsy	* still birth and termination of pregnancies * intervention: minimally invasive, virtual autopsy
Newborns	Conventional autopsy	* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy
Children and adolescents	Conventional autopsy	* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

University Hospital Zurich, Division of Neonatology; 🇨🇭 Zurich, ZH, Switzerland

Division of obstetrics, University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Zurich Institute for Forensic Medicine; 🇨🇭 Zurich, Switzerland

University Children's Hospital Zurich; 🇨🇭 Zurich, Switzerland