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
  Purpose

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
Stillbirths
Sudden Infant Death

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: March 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fetuses
Still birth and Termination of pregnancies
Children
Includes Newborns, Infants and Children

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

  • Lack of parental consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417962

Locations
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
Investigators
Principal Investigator: Andrew M Taylor, MD Great Ormond Street Hospital NHS Trust
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT01417962     History of Changes
Other Study ID Numbers: MR07
Study First Received: August 13, 2011
Last Updated: April 19, 2013
Health Authority: United Kingdom: Department of Health

Keywords provided by Thayyil, Sudhin:
Autopsy
MRI
Stillbirths
Neonatal death
Sudden Infant death

Additional relevant MeSH terms:
Death
Sudden Infant Death
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on August 28, 2014