The Paediatric Virtual Autopsy Trial

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

Tracking Information

• First Submitted Date: June 17, 2013
• First Posted Date: June 27, 2013
• Last Update Posted Date: March 10, 2020
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: The Paediatric Virtual Autopsy Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Stillbirth
• Newborn Death
• Sudden Infant Death

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 24, 2013): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 16 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christoph Rüegger, MD; +41 44 255 16 08; christoph.rueegger@usz.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01888380
• Other Study ID Numbers: Paediatric virtopsy
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Zurich
• Study Sponsor: University of Zurich
• Collaborators: Not Provided

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

• PRS Account: University of Zurich
• Verification Date: March 2020