Magnetic Resonance Imaging Autopsy Study (MARIAS)

This study has been completed.
Sponsor:
Collaborators:
Great Ormond Street Hospital for Children NHS Foundation Trust
University College London Hospitals
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin
ClinicalTrials.gov Identifier:
NCT01417962
First received: August 13, 2011
Last updated: April 19, 2013
Last verified: April 2013

August 13, 2011
April 19, 2013
March 2007
September 2011   (final data collection date for primary outcome measure)
Number of cases where the cause of death and/or major pathological lesions are detected [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01417962 on ClinicalTrials.gov Archive Site
  • MR appearance of death-induced artefacts. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of cases where there is a change in ante-mortem diagnosis following post-mortem MR imaging will be reported
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging Autopsy Study
Post Mortem Magnetic Resonance Imaging in the Fetus, Infant and Child: A Comparative Study With Conventional Autopsy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Stillbirths
  • Sudden Infant Death
Not Provided
  • Fetuses
    Still birth and Termination of pregnancies
  • Children
    Includes Newborns, Infants and Children

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

  • Lack of parental consent
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01417962
MR07
No
Sudhin Thayyil, Thayyil, Sudhin
Thayyil, Sudhin
  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • University College London Hospitals
Principal Investigator: Andrew M Taylor, MD Great Ormond Street Hospital NHS Trust
Thayyil, Sudhin
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP