The Paediatric Virtual Autopsy Trial

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT01888380
• Collaborator: (none)
• Enrollment: 105
• Locations: 4
• Arms: 3
• Actual Duration (Months): 56
• Patients Per Site: 26.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions [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 [8 weeks]

   Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.

2. MR Protocol [8 weeks]

   To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children

3. Change in the ante-mortem diagnosis [8 weeks]

   The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Division of Neonatology	Zurich	ZH	Switzerland	8091
2	Division of obstetrics, University Hospital Zurich	Zurich		Switzerland
3	University Children's Hospital Zurich	Zurich		Switzerland
4	Zurich Institute for Forensic Medicine	Zurich		Switzerland

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01888380
• Other Study ID Numbers: Paediatric virtopsy
• First Posted: Jun 27, 2013
• Last Update Posted: Jan 11, 2021
• Last Verified: Mar 1, 2020

• Keywords provided by University of Zurich: Autopsy; Minimally invasive; Foetuses; Newborns; Children; Adolescents
• Additional relevant MeSH terms: Stillbirth; Death; Infant Death; Sudden Infant Death

Study Results

No Results Posted as of Jan 11, 2021