Minimally invasive, virtual autopsy
ProcedurePost-mortem cross-sectional imaging with CT-guided biopsy
Other names: Virtopsy
NCT Number: NCT01888380
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.
Looking for future studies?
Notify MeUp to 16 year
All sexes
Interventional
Not applicable
University Hospital Zurich, Division of Neonatology, Zurich, Canton of Zurich, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post-mortem cross-sectional imaging with CT-guided biopsy
Other names: Virtopsy
Other names: Postmortem
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.
Time frame: 8 weeks
Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
Time frame: 8 weeks
To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
Time frame: 8 weeks
The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.
University of Zurich
Other
Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02189265
Death, Death, Sudden
Amsterdam, North Holland, Netherlands
View Trial DetailsNCT02039583
Death, Death, Sudden
Edinburgh, Midlothian, United Kingdom
View Trial DetailsNCT03775954
Anemia, Anemia, Neonatal
Madison, Wisconsin, United States
View Trial DetailsNCT03438110
Death, Female Urogenital Diseases and Pregnancy Complications
Davangere, India
View Trial Details