ClinicalTrials.gg
CompletedNCT01417962MARIASUpdated Apr 22, 2013

Magnetic Resonance Imaging Autopsy Study

An observational study in Stillbirths and Sudden Infant Death, sponsored by Thayyil, Sudhin. Completed at 2 sites in United Kingdom. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by Thayyil, Sudhin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
Up to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Stillbirth with a site in United Kingdom — 4 open to participants now, 4 under way, none of them phase 3. Stillbirth · United Kingdom.

Planned enrollment
10th of 14
400 · median 989
Started
2007
the only one that year
Observational
14 of 16
4 open now
Registered
2nd of 16
by date
Lead sponsor
2 of 16
Thayyil, Sudhin

Among the 16 studies in Stillbirth with a site in United Kingdom, this one is the 10th largest by planned enrollment of the 14 observational ones, is the only one that started in 2007, is one of 14 observational ones, and was the 2nd registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

Observationalthis study14 · 4 open
No phase2 · 0 open

By the year they started

First in 1995; this study’s year is marked. 1 started in 2007.

Size and results

Median enrollment 217,136 across the 2 interventional studies, 989 across the 14 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 16 studies in Stillbirth with a site in United Kingdom, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Stillbirths
  • Sudden Infant Death

Keywords

  • Autopsy
  • MRI
  • Stillbirths
  • Neonatal death
  • Sudden Infant death
04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion criteria

Exclusion Criteria:

  • Lack of parental consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)

Groups and cohorts

  • Fetuses

    Still birth and Termination of pregnancies

  • Children

    Includes Newborns, Infants and Children

06

What researchers measure

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

    Time frame: 6 weeks

Secondary outcomes

  1. MR appearance of death-induced artefacts.

    The common artefacts seen on post-mortem MR imaging will be described

    Time frame: 6 weeks

  2. 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

    Time frame: 6 weeks

07

Study locations

2 sites
  • Great Ormond Street Hospital
    London, United Kingdom
  • University College Hospital
    London, United Kingdom
08

References and documents

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. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10. PubMed 21740313 ↗
  • 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. PubMed 21349673 ↗
  • 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. PubMed 20661883 ↗
  • 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. PubMed 20515965 ↗
  • 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. PubMed 19910149 ↗
  • 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. PubMed 19665645 ↗
  • 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. PubMed 19282335 ↗
  • 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. PubMed 18768277 ↗
  • 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. Erratum In: Lancet. 2008 Oct 4;372(9645):1222. PubMed 18761215 ↗
  • 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. PubMed 22347922 ↗
  • 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. PubMed 26050535 ↗
  • 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. PubMed 25043483 ↗
  • 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. PubMed 24647275 ↗
  • 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. PubMed 22192497 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2007, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2011
First posted
Aug 16, 2011
Start
Mar 2007
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Last update
Apr 22, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01417962
Lead sponsor
Thayyil, Sudhin
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust, University College London Hospitals
Responsible party
Sudhin Thayyil (Consultant Neonatologist, Thayyil, Sudhin) — Principal investigator
First posted
Aug 16, 2011
Start date
Mar 2007
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Apr 22, 2013

Study contacts

Andrew M Taylor, MD
principal investigator · Great Ormond Street Hospital NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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