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The Paediatric Virtual Autopsy Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888380
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.


Condition or disease Intervention/treatment Phase
Stillbirth Newborn Death Sudden Infant Death Procedure: Minimally invasive, virtual autopsy Procedure: Conventional autopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Virtopsy

Procedure: Conventional autopsy
Other Name: 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 Name: Virtopsy

Procedure: Conventional autopsy
Other Name: 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 Name: Virtopsy

Procedure: Conventional autopsy
Other Name: Postmortem


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888380


Locations
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Switzerland
University Hospital Zurich, Division of Neonatology
Zurich, ZH, Switzerland, 8091
Division of obstetrics, University Hospital Zurich
Zurich, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Zurich Institute for Forensic Medicine
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Study Director: Hans Ulrich Bucher, MD, Prof University Hospital Zurich, Division of Neonatology
Principal Investigator: Christoph Rüegger, MD University Hospital Zurich, Division of Neonatology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01888380    
Other Study ID Numbers: Paediatric virtopsy
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: March 2020
Keywords provided by University of Zurich:
Autopsy
Minimally invasive
Foetuses
 Newborns
Children
Adolescents
Additional relevant MeSH terms:
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Stillbirth
Death
Infant Death
Sudden Infant Death
Pathologic Processes
 Fetal Death
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Death, Sudden