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The Paediatric Virtual Autopsy Trial

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ClinicalTrials.gov Identifier: NCT01888380
Recruitment Status : Recruiting
First Posted : June 27, 2013
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date March 10, 2020
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions [ Time Frame: 4 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • Clinical indication [ Time Frame: 8 weeks ]
    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
  • MR Protocol [ Time Frame: 8 weeks ]
    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Clinical indication [ Time Frame: 4 weeks ]
    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
  • MR Protocol [ Time Frame: 4 weeks ]
    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
  • Change in the ante-mortem diagnosis [ Time Frame: 4 weeks ]
    The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Paediatric Virtual Autopsy Trial
Official Title  ICMJE Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stillbirth
  • Newborn Death
  • Sudden Infant Death
Intervention  ICMJE
  • Procedure: Minimally invasive, virtual autopsy
    Post-mortem cross-sectional imaging with CT-guided biopsy
    Other Name: Virtopsy
  • Procedure: Conventional autopsy
    Other Name: Postmortem
Study Arms  ICMJE
  • Experimental: Foetuses
    • still birth and termination of pregnancies
    • intervention: minimally invasive, virtual autopsy
    Interventions:
    • Procedure: Minimally invasive, virtual autopsy
    • Procedure: Conventional autopsy
  • Experimental: Newborns
    • who died of natural- and non-natural cause
    • intervention: minimally invasive, virtual autopsy
    Interventions:
    • Procedure: Minimally invasive, virtual autopsy
    • Procedure: Conventional autopsy
  • Experimental: Children and adolescents
    • who died of natural- and non-natural cause
    • intervention: minimally invasive, virtual autopsy
    Interventions:
    • Procedure: Minimally invasive, virtual autopsy
    • Procedure: Conventional autopsy
Publications * Rüegger CM, Bartsch C, Martinez RM, Ross S, Bolliger SA, Koller B, Held L, Bruder E, Bode PK, Caduff R, Frey B, Schäffer L, Bucher HU. Minimally invasive, imaging guided virtual autopsy compared to conventional autopsy in foetal, newborn and infant cases: study protocol for the paediatric virtual autopsy trial. BMC Pediatr. 2014 Jan 20;14:15. doi: 10.1186/1471-2431-14-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christoph Rüegger, MD +41 44 255 16 08 christoph.rueegger@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888380
Other Study ID Numbers  ICMJE Paediatric virtopsy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hans Ulrich Bucher, MD, Prof University Hospital Zurich, Division of Neonatology
Principal Investigator: Christoph Rüegger, MD University Hospital Zurich, Division of Neonatology
PRS Account University of Zurich
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP