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History of Changes for Study: NCT01888380
Paediatric Virtual Autopsy Study: Minimally Invasive, Imaging Guided Virtual Autopsy Compared to Conventional Autopsy
Latest version (submitted January 7, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 24, 2013 None (earliest Version on record)
2 November 25, 2013 Study Status, Outcome Measures, Arms and Interventions, Study Identification, Conditions and Study Description
3 January 20, 2014 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 12, 2015 Arms and Interventions, Contacts/Locations, Study Design, Study Description, Oversight, Study Status and Study Identification
5 December 3, 2015 Study Status
6 October 26, 2016 Study Status
7 May 2, 2017 Study Status
8 May 2, 2018 Study Status
9 March 9, 2020 Study Status
10 January 7, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01888380
Submitted Date:  June 24, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: Paediatric virtopsy
Brief Title: Paediatric Virtual Autopsy Study: Minimally Invasive, Imaging Guided Virtual Autopsy Compared to Conventional Autopsy
Official Title: Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Fetuses, Neonates, Infants and Children
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: June 2016 [Anticipated]
Study Completion: June 2016 [Anticipated]
First Submitted: June 17, 2013
First Submitted that
Met QC Criteria:
June 24, 2013
First Posted: June 27, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 24, 2013
Last Update Posted: June 27, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Zurich
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

With this prospective interdisciplinary trial, we aim at comparing the performance of minimally invasive virtual autopsy with conventional autopsy. Fetuses, newborns and children up to 16 years of age referred for autopsy at three different institutions (Department of Neonatology of the University Hospital Zurich, Children's University Hospital Zurich and Zurich Institute for Forensic Medicine) will be eligible for recruitment.

All recruited cases will undergo postmortem cross-sectional imaging (MR imaging and CT) and CT-guided biopsies performed by a multifunctional robotic system allowing for automated biopsies. Both, cross sectional imaging data as well as the histologic findings will be reported by an expert group of forensic radiologists and pathologists blinded to the results of conventional autopsy with regards to the likely final diagnosis and major pathological findings. These diagnoses will finally be compared with the results from conventional autopsy performed by experienced pediatric or perinatal pathologists, the autopsy results being the gold standard. The study is planned for 100 patients or for three years.

Detailed Description:
Open or close this module Conditions
Conditions: Stillbirth
Newborn Death
Sudden Infant Death
Keywords: Autopsy
Minimally invasive
Fetuses
Newborns
Children
Adolescents
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 3
Masking: (masked roles unspecified)
Allocation: Non-Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Fetuses
Still birth and termination of pregnancies
Procedure: Minimally invasive, virtual autopsyProcedure: Conventional autopsy
Experimental: Newborns
Who died of natural- and non-natural cause
Procedure: Minimally invasive, virtual autopsyProcedure: Conventional autopsy
Experimental: Children and adolescents
Who died of natural- and non-natural cause
Procedure: Minimally invasive, virtual autopsyProcedure: Conventional autopsy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Clinical indication
[ Time Frame: 4 weeks ]

Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
2. MR Protocol
[ Time Frame: 4 weeks ]

To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
3. 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.
Open or close this module Eligibility
Minimum Age:
Maximum Age: 16 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Christoph Rüegger, MD
Telephone: +41 44 255 16 08
Email: christoph.rueegger@usz.ch
Study Officials: Hans Ulrich Bucher, MD, Prof
Study Director
University Hospital Zurich, Division of Neonatology
Christoph Rüegger, MD
Principal Investigator
University Hospital Zurich, Division of Neonatology
Locations: Switzerland
Division of obstetrics, University Hospital Zurich
Zurich, Switzerland
Contact:Contact: Leonhard Schäffer, MD leonhard.schaeffer@usz.ch
Contact:Principal Investigator: Leonhard Schäffer, MD
University Children's Hospital Zurich
Zurich, Switzerland
Contact:Contact: Bernhard Frey, MD, Prof bernhard.frey@kispi.uzh.ch
Contact:Principal Investigator: Bernhard Frey, MD, Prof.
Zurich Institute for Forensic Medicine
Zurich, Switzerland
Contact:Contact: Christine Bartsch, MD christine.bartsch@irm.uzh.ch
Contact:Principal Investigator: Christine Bartsch, MD
Switzerland, ZH
University Hospital Zurich, Division of Neonatology
Zurich, ZH, Switzerland, 8091
Contact:Contact: Christoph Rüegger, MD christoph.rueegger@usz.ch
Contact:Principal Investigator: Christoph Rüegger, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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