StillbirthNCT01888380
The Paediatric Virtual Autopsy Trial
A study testing Minimally invasive, virtual autopsy and Conventional autopsy in people with Stillbirth and Newborn Death, run by University of Zurich at 4 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Stillbirth, Newborn Death, Sudden Infant Death
- What is being tested?
- Minimally invasive, virtual autopsy and Conventional autopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Jan 2014to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Deceased infants who are donors of organs
- Lack of parental consent
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital Zurich, Division of Neonatology
Zurich, Canton of Zurich, 8091
Division of obstetrics, University Hospital Zurich
Zurich
University Children's Hospital Zurich
Zurich
Zurich Institute for Forensic Medicine
Zurich
About this study
Official title: Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
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.
- Conditions
- Stillbirth, Newborn Death, Sudden Infant Death
- Being tested
- Minimally invasive, virtual autopsy, Conventional autopsy
- Keywords
- Autopsy, Minimally invasive, Foetuses, Newborns, Children, Adolescents
- Medical subject headings
- Stillbirth, Perinatal Death, Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive, virtual autopsyProcedure or surgery
Also called Virtopsy
Post-mortem cross-sectional imaging with CT-guided biopsy
Conventional autopsyProcedure or surgery
Also called Postmortem
| Study group | Role | What they receive |
|---|---|---|
| Foetuses | Experimental | * still birth and termination of pregnancies
* intervention: minimally invasive, virtual autopsy Receives: Procedure: Minimally invasive, virtual autopsy; Procedure: Conventional autopsy |
| Newborns | Experimental | * who died of natural- and non-natural cause
* intervention: minimally invasive, virtual autopsy Receives: Procedure: Minimally invasive, virtual autopsy; Procedure: Conventional autopsy |
| Children and adolescents | Experimental | * who died of natural- and non-natural cause
* intervention: minimally invasive, virtual autopsy Receives: Procedure: Minimally invasive, virtual autopsy; Procedure: Conventional autopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Clinical indication
Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
Measured: 8 weeks
MR Protocol
To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study start1 Jan 2014
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Ulrich Bucher, MD, Prof, Study director, University Hospital Zurich, Division of NeonatologyChristoph Rüegger, MD, Principal investigator, University Hospital Zurich, Division of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888380
- Sponsor's protocol ID
- Paediatric virtopsy
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2013
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35918685Ruegger 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.
PubMed 24438163
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
- ClinicalTrials.gov ID
- NCT01888380
- Acronym / sponsor ID
- Paediatric virtopsy
- Conditions
- Stillbirth, Newborn Death, Sudden Infant Death
- Keywords
- Autopsy, Minimally invasive, Foetuses, Newborns, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foetuses | Experimental | Procedure: Minimally invasive, virtual autopsy, Procedure: Conventional autopsy* still birth and termination of pregnancies * intervention: minimally invasive, virtual autopsy |
| Newborns | Experimental | Procedure: Minimally invasive, virtual autopsy, Procedure: Conventional autopsy* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy |
| Children and adolescents | Experimental | Procedure: Minimally invasive, virtual autopsy, Procedure: Conventional autopsy* who died of natural- and non-natural cause * intervention: minimally invasive, virtual autopsy |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Deceased infants who are donors of organs
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive, virtual autopsyAlso: VirtopsyPost-mortem cross-sectional imaging with CT-guided biopsy | Procedure or surgery | Children and adolescents, Foetuses, Newborns |
| Conventional autopsyAlso: Postmortem | Procedure or surgery | Children and adolescents, Foetuses, Newborns |
Primary outcome
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions
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.
3 secondary outcomes
Clinical indication
Time frame: 8 weeks
MR Protocol
Time frame: 8 weeks
Change in the ante-mortem diagnosis
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 35918685Ruegger 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.
- Derived from this study: PubMed 24438163Ruegger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Ulrich Bucher, MD, Prof study director
University Hospital Zurich, Division of Neonatology
Christoph Rüegger, MD principal investigator
University Hospital Zurich, Division of Neonatology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive, virtual autopsy and Conventional autopsy in people with Stillbirth and Newborn Death, run by University of Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01888380, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.