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Completed

NCT Number: NCT01888380

The Paediatric Virtual Autopsy Trial

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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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Division of Neonatology, Zurich, Canton of Zurich, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive, virtual autopsy

Procedure

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

Other names: Virtopsy

Conventional autopsy

Procedure

Other names: Postmortem

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical indication

    Time frame: 8 weeks

    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.

  2. MR Protocol

    Time frame: 8 weeks

    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2013
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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