Magnetic Resonance Imaging Autopsy Study (MARIAS)
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|ClinicalTrials.gov Identifier: NCT01417962|
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : April 22, 2013
The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and determination of the cause of death.
This will be achieved by acquiring a database of whole-body, post-mortem MR images in approximately 400 fetuses, infants and children, over a 3 years period. Images will be acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert group of paediatric radiologists, and compared, in a blinded fashion, with reports from conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly, the post-mortem information will be assessed with reference to the needs of the parents, referring clinicians and HM Coroners. The detection of central nervous system abnormalities will be assessed separately.
The study will be performed across two sites: A dedicated children's hospital (Great Ormond Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal departments (University College London Hospital), which are linked academically by University College London.
Co-ordination of the project will be managed by a steering committee, which will ensure accurate collation and comparison of the data.
|Condition or disease|
|Stillbirths Sudden Infant Death|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Post Mortem Magnetic Resonance Imaging in the Fetus, Infant and Child: A Comparative Study With Conventional Autopsy|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Still birth and Termination of pregnancies
Includes Newborns, Infants and Children
- Number of cases where the cause of death and/or major pathological lesions are detected [ Time Frame: 6 weeks ]Conventional autopsy will be considered as the gold standard. The number (%) of cases where post-mortem MR imaging identifies the cause of death and/or major pathological lesions when compared with conventional autopsy will be reported
- MR appearance of death-induced artefacts. [ Time Frame: 6 weeks ]The common artefacts seen on post-mortem MR imaging will be described
- Number of cases where there is a change in ante-mortem diagnosis [ Time Frame: 6 weeks ]Number of cases where there is a change in ante-mortem diagnosis following post-mortem MR imaging will be reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417962
|Great Ormond Street Hospital|
|London, United Kingdom|
|University College Hospital|
|London, United Kingdom|
|Principal Investigator:||Andrew M Taylor, MD||Great Ormond Street Hospital NHS Trust|