Magnetic Resonance Imaging Autopsy Study (MARIAS)

April 19, 2013 updated by: Sudhin Thayyil, Thayyil, Sudhin

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • University College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

  • Lack of parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Fetuses
Still birth and Termination of pregnancies
Children
Includes Newborns, Infants and Children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases where the cause of death and/or major pathological lesions are detected
Time Frame: 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
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thayyil, Sudhin

Collaborators

University College London Hospitals
Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

  • Principal Investigator: Andrew M Taylor, MD, Great Ormond Street Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 13, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 19, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sudden Infant Death

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe