The Paediatric Virtual Autopsy Trial

January 7, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Division of obstetrics, University Hospital Zurich
      • Zurich, Switzerland
        • University Children's Hospital Zurich
      • Zurich, Switzerland
        • Zurich Institute for Forensic Medicine
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical indication
Time Frame: 8 weeks
Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
8 weeks
MR Protocol
Time Frame: 8 weeks
To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Director: Hans Ulrich Bucher, MD, Prof, University Hospital Zurich, Division of Neonatology
  • Principal Investigator: Christoph Rüegger, MD, University Hospital Zurich, Division of Neonatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paediatric virtopsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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