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Magnetic Resonance Imaging Autopsy Study (MARIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01417962
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : April 22, 2013
Great Ormond Street Hospital for Children NHS Foundation Trust
University College London Hospitals
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. MR appearance of death-induced artefacts. [ Time Frame: 6 weeks ]
    The common artefacts seen on post-mortem MR imaging will be described

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be performed across two hospital sites: Great Ormond Street Hospital for Children (GOSH) and University College London Hospitals (UCLH). Both of these hospitals are associated with a single academic institution - University College London (UCL). Consecutive fetuses, newborns and children referred for autopsy at these two hospitals will be eligible for recruitment. All recruited cases will have conventional post-mortem MR imaging at 1.5 Tesla and conventional autopsy. CT imaging will be performed in suspected traumatic injuries and skeletal dysplasias.

Inclusion Criteria:

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

  • Lack of parental consent

Information from the National Library of Medicine

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 identifier (NCT number): NCT01417962

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United Kingdom
Great Ormond Street Hospital
London, United Kingdom
University College Hospital
London, United Kingdom
Sponsors and Collaborators
Thayyil, Sudhin
Great Ormond Street Hospital for Children NHS Foundation Trust
University College London Hospitals
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Principal Investigator: Andrew M Taylor, MD Great Ormond Street Hospital NHS Trust
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin Identifier: NCT01417962    
Other Study ID Numbers: MR07
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by Sudhin Thayyil, Thayyil, Sudhin:
Neonatal death
Sudden Infant death
Additional relevant MeSH terms:
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Infant Death
Sudden Infant Death
Pathologic Processes
Fetal Death
Pregnancy Complications
Death, Sudden