Magnetic Resonance Imaging Autopsy Study

NCT01417962 | Completed

• 1 other identifier: MR07
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stillbirths; Sudden Infant Death

Keywords

Autopsy; MRI; Stillbirths; Neonatal death; Sudden Infant death

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• MR appearance of death-induced artefacts.

  6 weeks

• Number of cases where there is a change in ante-mortem diagnosis

  6 weeks

Study Arms (2)

Fetuses

Still birth and Termination of pregnancies

Children

Includes Newborns, Infants and Children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Fetuses, newborns and Infants undergoing conventional autopsy

You may not qualify if:

• Lack of parental consent

Sponsors & Collaborators

• Thayyil, Sudhin: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• University College London Hospitals: collaborator

Study Sites (2)

Great Ormond Street Hospital

London, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

Related Publications (14)

• 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. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10.

  PMID: 21740313 RESULT

• 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):e232-8. doi: 10.1016/j.ejrad.2011.01.105. Epub 2011 Feb 23.

  PMID: 21349673 RESULT

• 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/pd.2534.

  PMID: 20661883 RESULT

• 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.

  PMID: 20515965 RESULT

• 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. doi: 10.1016/j.ejrad.2009.10.007. Epub 2009 Nov 11.

  PMID: 19910149 RESULT

• 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. doi: 10.1016/S0140-6736(09)60913-2.

  PMID: 19665645 RESULT

• 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. doi: 10.1136/adc.2008.150904. Epub 2009 Mar 12.

  PMID: 19282335 RESULT

• 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. doi: 10.1016/j.ejrad.2008.07.013. Epub 2008 Sep 2.

  PMID: 18768277 RESULT

• 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. No abstract available.

  PMID: 18761215 RESULT

• 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. doi: 10.1007/s13244-010-0028-5. Epub 2010 Jun 19.

  PMID: 22347922 RESULT

• Arthurs OJ, Thayyil S, Pauliah SS, Jacques TS, Chong WK, Gunny R, Saunders D, Addison S, Lally P, Cady E, Jones R, Norman W, Scott R, Robertson NJ, Wade A, Chitty L, Taylor AM, Sebire NJ; Magnetic Resonance Imaging Autopsy Study (MaRIAS) Collaborative Group. Diagnostic accuracy and limitations of post-mortem MRI for neurological abnormalities in fetuses and children. Clin Radiol. 2015 Aug;70(8):872-80. doi: 10.1016/j.crad.2015.04.008. Epub 2015 Jun 6.

  PMID: 26050535 DERIVED

• Arthurs OJ, Thayyil S, Addison S, Wade A, Jones R, Norman W, Scott R, Robertson NJ, Chitty LS, Taylor AM, Sebire NJ, Offiah AC; Magnetic Resonance Imaging Autopsy Study (MaRIAS) Collaborative Group. Diagnostic accuracy of postmortem MRI for musculoskeletal abnormalities in fetuses and children. Prenat Diagn. 2014 Dec;34(13):1254-61. doi: 10.1002/pd.4460. Epub 2014 Aug 6.

  PMID: 25043483 DERIVED

• Taylor AM, Sebire NJ, Ashworth MT, Schievano S, Scott RJ, Wade A, Chitty LS, Robertson N, Thayyil S; Magnetic Resonance Imaging Autopsy Study Collaborative Group. Postmortem cardiovascular magnetic resonance imaging in fetuses and children: a masked comparison study with conventional autopsy. Circulation. 2014 May 13;129(19):1937-44. doi: 10.1161/CIRCULATIONAHA.113.005641. Epub 2014 Mar 19.

  PMID: 24647275 DERIVED

• 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. doi: 10.1186/1471-2431-11-120.

  PMID: 22192497 DERIVED

MeSH Terms

Conditions

Stillbirth; Sudden Infant Death; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Infant Death

Study Officials

• Andrew M Taylor, MD

  Great Ormond Street Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: August 13, 2011
• First Posted: August 16, 2011
• Study Start: March 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

GB (2)