Magnetic Resonance Imaging Autopsy Study

Sudden Infant Death Clinical Trial

— MARIAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417962
• Other study ID #: MR07
• Status: Completed
• Phase: N/A
• First received: August 13, 2011
• Last updated: April 19, 2013
• Start date: March 2007
• Est. completion date: September 2011

Study information

• Verified date: April 2013
• Source: Thayyil, Sudhin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

• Lack of parental consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stillbirths
• Sudden Infant Death

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	University College Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Thayyil, Sudhin	Great Ormond Street Hospital for Children NHS Foundation Trust, University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Schievano S, Sebire NJ, Robertson NJ, Taylor AM, Thayyil S. Reconstruction of fetal and infant anatomy using rapid prototyping of post-mortem MR images. Insights Imaging. 2010 Sep;1(4):281-286. Epub 2010 Jun 19. — View Citation

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 — View Citation

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 — View Citation

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. doi: 10.1002 — View Citation

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 — View Citation

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 T1 and T2 in fetuses, newborns and infants. Eur J Radiol. 2012 Mar;81(3):e232 — View Citation

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. doi: 10.1016/S0140-6736(08)61298-2. Erratum in: Lancet. 2008 Oct 4;372(9645):1222. — View Citation

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 success — View Citation

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 resona — View Citation

Thayyil S. Less invasive autopsy: an evidenced based approach. Arch Dis Child. 2011 Jul;96(7):681-7. doi: 10.1136/adc.2009.165704. Epub 2010 Jun 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases where the cause of death and/or major pathological lesions are detected	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	6 weeks	No
Secondary	MR appearance of death-induced artefacts.	The common artefacts seen on post-mortem MR imaging will be described	6 weeks	No
Secondary	Number of cases where there is a change in ante-mortem diagnosis	Number of cases where there is a change in ante-mortem diagnosis following post-mortem MR imaging will be reported	6 weeks	No