Clinical trial NCT01888380: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stillbirth
Newborn Death
Sudden Infant Death
Keywords: Autopsy
Minimally invasive
Foetuses
Newborns
Children
Adolescents
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 105
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical indication
timeFrame: 8 weeks
measure: MR Protocol
timeFrame: 8 weeks
measure: Change in the ante-mortem diagnosis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neonatology
state: ZH
city: Zurich
country: Switzerland
facility: Division of obstetrics, University Hospital Zurich
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
city: Zurich
country: Switzerland
facility: Zurich Institute for Forensic Medicine
Study officials:
affiliation: University Hospital Zurich, Division of Neonatology
name: Hans Ulrich Bucher, MD, Prof
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Neonatology
name: Christoph Rüegger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ruegger 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.