The Paediatric Virtual Autopsy Trial

Stillbirth Clinical Trial

Official title:

Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888380
• Other study ID #: Paediatric virtopsy
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infant Death
• Newborn Death
• Stillbirth
• Sudden Infant Death

Intervention

Procedure:
• Minimally invasive, virtual autopsy
Post-mortem cross-sectional imaging with CT-guided biopsy
• Conventional autopsy

Locations

Country	Name	City	State
Switzerland	Division of obstetrics, University Hospital Zurich	Zurich
Switzerland	University Children's Hospital Zurich	Zurich
Switzerland	University Hospital Zurich, Division of Neonatology	Zurich	ZH
Switzerland	Zurich Institute for Forensic Medicine	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical indication	Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.	8 weeks
Secondary	MR Protocol	To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children	8 weeks
Secondary	Change in the ante-mortem diagnosis	The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.	8 weeks