Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foetuses | Experimental |
|
|
| Newborns | Experimental |
|
|
| Children and adolescents | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive, virtual autopsy | Procedure | Post-mortem cross-sectional imaging with CT-guided biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical indication | Number of false positive and false negative results of virtual autopsy will be calculated for each organ system. | 8 weeks |
| MR Protocol | To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans Ulrich Bucher, MD, Prof | University Hospital Zurich, Division of Neonatology | Study Director |
| Christoph Rüegger, MD | University Hospital Zurich, Division of Neonatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Neonatology | Zurich | Canton of Zurich | 8091 | Switzerland | ||
| Division of obstetrics, University Hospital Zurich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35918685 | Derived | 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. | |
| 24438163 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D066087 | Perinatal Death |
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001344 | Autopsy |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional autopsy | Procedure |
|
|
| 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. | 8 weeks |
| Zurich |
| Switzerland |
| University Children's Hospital Zurich | Zurich | Switzerland |
| Zurich Institute for Forensic Medicine | Zurich | Switzerland |
| 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. |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003645 | Death, Sudden |
| D066088 | Infant Death |