The Paediatric Virtual Autopsy Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Stillbirth Newborn Death Sudden Infant Death

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Foetuses

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

Group Type EXPERIMENTAL

Minimally invasive, virtual autopsy

Intervention Type PROCEDURE

Post-mortem cross-sectional imaging with CT-guided biopsy

Conventional autopsy

Intervention Type PROCEDURE

Newborns

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

Group Type EXPERIMENTAL

Minimally invasive, virtual autopsy

Intervention Type PROCEDURE

Post-mortem cross-sectional imaging with CT-guided biopsy

Conventional autopsy

Intervention Type PROCEDURE

Children and adolescents

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

Group Type EXPERIMENTAL

Minimally invasive, virtual autopsy

Intervention Type PROCEDURE

Post-mortem cross-sectional imaging with CT-guided biopsy

Conventional autopsy

Intervention Type PROCEDURE

Interventions

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Minimally invasive, virtual autopsy

Post-mortem cross-sectional imaging with CT-guided biopsy

Intervention Type PROCEDURE

Conventional autopsy

Intervention Type PROCEDURE

Other Intervention Names

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Virtopsy Postmortem

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).