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Completed

NCT Number: NCT01417962

Magnetic Resonance Imaging Autopsy Study

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Ormond Street Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion criteria

  • Lack of parental consent

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Thayyil, Sudhin

Indiv

Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • University College London Hospitals

Registry information

Official study title

Post Mortem Magnetic Resonance Imaging in the Fetus, Infant and Child: A Comparative Study With Conventional Autopsy

Acronym: MARIAS

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 16, 2011
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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