Magnetic Resonance Imaging Autopsy Study

Completed

• Conditions: Stillbirths; Sudden Infant Death

• Registration Number: NCT01417962
• Lead Sponsor: Thayyil, Sudhin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2011-08-13
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria

• Lack of parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cases where the cause of death and/or major pathological lesions are detected	6 weeks	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

Name	Time	Method
MR appearance of death-induced artefacts.	6 weeks	The common artefacts seen on post-mortem MR imaging will be described
Number of cases where there is a change in ante-mortem diagnosis	6 weeks	Number of cases where there is a change in ante-mortem diagnosis following post-mortem MR imaging will be reported

Trial Locations

Locations (2)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

University College Hospital; 🇬🇧 London, United Kingdom