The Paediatric Virtual Autopsy Trial
Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
1 other identifier
interventional
105
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedJanuary 11, 2021
March 1, 2020
4.6 years
June 17, 2013
January 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions
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 Outcomes (3)
Clinical indication
8 weeks
MR Protocol
8 weeks
Change in the ante-mortem diagnosis
8 weeks
Study Arms (3)
Foetuses
EXPERIMENTAL* still birth and termination of pregnancies * intervention: minimally invasive, virtual autopsy
Newborns
EXPERIMENTAL* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy
Children and adolescents
EXPERIMENTAL* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy
Interventions
Post-mortem cross-sectional imaging with CT-guided biopsy
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Deceased infants who are donors of organs
- Lack of parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University Hospital Zurich, Division of Neonatology
Zurich, Canton of Zurich, 8091, Switzerland
Division of obstetrics, University Hospital Zurich
Zurich, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Zurich Institute for Forensic Medicine
Zurich, Switzerland
Related Publications (2)
Ruegger CM, Gascho D, Bode PK, Bruder E, Haslinger C, Ross S, Schmid K, Knopfli C, Hofer LJ, Held L, Martinez RM, Bucher HU; Virtopsy Study Group. Post-mortem magnetic resonance imaging with computed tomography-guided biopsy for foetuses and infants: a prospective, multicentre, cross-sectional study. BMC Pediatr. 2022 Aug 3;22(1):464. doi: 10.1186/s12887-022-03519-4.
PMID: 35918685DERIVEDRuegger CM, Bartsch C, Martinez RM, Ross S, Bolliger SA, Koller B, Held L, Bruder E, Bode PK, Caduff R, Frey B, Schaffer 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.
PMID: 24438163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans Ulrich Bucher, MD, Prof
University Hospital Zurich, Division of Neonatology
- PRINCIPAL INVESTIGATOR
Christoph Rüegger, MD
University Hospital Zurich, Division of Neonatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 27, 2013
Study Start
January 1, 2014
Primary Completion
July 31, 2018
Study Completion
August 31, 2018
Last Updated
January 11, 2021
Record last verified: 2020-03