Magnetic Resonance Imaging Autopsy Study - Full Text View

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:

MedlinePlus related topics: MRI Scans Stillbirth Sudden Infant Death Syndrome

U.S. FDA Resources

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

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:

Sebire NJ, Weber MA, Thayyil S, Mushtaq I, Taylor A, Chitty LS. Minimally invasive perinatal autopsies using magnetic resonance imaging and endoscopic postmortem examination ("keyhole autopsy"): feasibility and initial experience. J Matern Fetal Neonatal Med. 2011 Aug 10; [Epub ahead of print]

Thayyil S, De Vita E, Sebire NJ, Bainbridge A, Thomas D, Gunny R, Chong K, Lythgoe MF, Golay X, Robertson NJ, Cady EB, Taylor AM. Post-mortem cerebral magnetic resonance imaging T(1) and T(2) in fetuses, newborns and infants. Eur J Radiol. 2011 Feb 22; [Epub ahead of print]

Thayyil S, Chitty LS, Robertson NJ, Taylor AM, Sebire NJ. Minimally invasive fetal postmortem examination using magnetic resonance imaging and computerised tomography: current evidence and practical issues. Prenat Diagn. 2010 Aug;30(8):713-8. Review.

Thayyil S. Less invasive autopsy: an evidenced based approach. Arch Dis Child. 2011 Jul;96(7):681-7. Epub 2010 Jun 1. Review.

Thayyil S, Chandrasekaran M, Chitty LS, Wade A, Skordis-Worrall J, Bennett-Britton I, Cohen M, Withby E, Sebire NJ, Robertson NJ, Taylor AM. Diagnostic accuracy of post-mortem magnetic resonance imaging in fetuses, children and adults: a systematic review. Eur J Radiol. 2010 Jul;75(1):e142-8. Epub 2009 Nov 11. Review.

Thayyil S, Cleary JO, Sebire NJ, Scott RJ, Chong K, Gunny R, Owens CM, Olsen OE, Offiah AC, Parks HG, Chitty LS, Price AN, Yousry TA, Robertson NJ, Lythgoe MF, Taylor AM. Post-mortem examination of human fetuses: a comparison of whole-body high-field MRI at 9.4 T with conventional MRI and invasive autopsy. Lancet. 2009 Aug 8;374(9688):467-75.

Thayyil S, Robertson NJ, Scales A, Weber MA, Jacques TS, Sebire NJ, Taylor AM; MaRIAS (Magnetic Resonance Imaging Autopsy Study) Collaborative Group. Prospective parental consent for autopsy research following sudden unexpected childhood deaths: a successful model. Arch Dis Child. 2009 May;94(5):354-8. Epub 2009 Mar 12.

Thayyil S, Schievano S, Robertson NJ, Jones R, Chitty LS, Sebire NJ, Taylor AM; MaRIAS (Magnetic Resonance Imaging Autopsy Study) Collaborative group. A semi-automated method for non-invasive internal organ weight estimation by post-mortem magnetic resonance imaging in fetuses, newborns and children. Eur J Radiol. 2009 Nov;72(2):321-6. Epub 2008 Sep 2.

Thayyil S, Robertson NJ, Scales A, Sebire NJ, Taylor AM. Parental consent for research and sudden infant death. Lancet. 2008 Aug 30;372(9640):715. No abstract available. Erratum in: Lancet. 2008 Oct 4;372(9645):1222.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thayyil S, Sebire NJ, Chitty LS, Wade A, Olsen O, Gunny RS, Offiah A, Saunders DE, Owens CM, Chong WK, Robertson NJ, Taylor AM. Post mortem magnetic resonance imaging in the fetus, infant and child: a comparative study with conventional autopsy (MaRIAS Protocol). BMC Pediatr. 2011 Dec 22;11:120.

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 June 17, 2013

Magnetic Resonance Imaging Autopsy Study (MARIAS)