NCT00686530

Brief Summary

Examination of the fetal brain at autopsy is technically challenging because of marked fragility of the brain tissue. Studies have found postmortem fetal MR to be particularly useful in examining gross structural abnormalities in fetal brain and spine. We have recently included postmortem MR as part of the radiological studies for fetal autopsy workup. Using the same MR data, the development of normal layering of the brain, also called laminar organization, can also be assessed. This laminar organization of the brain is often disturbed in congenital malformations. Our aim is to study the disturbance in laminar organization of the postmortem brain with MR, using structural MR and a type of MR sequence called diffusion tensor imaging, which is well suited for assessing the organization of the developing brain. The postmortem MR findings will be compared with gold standard of histopathology. This will help us understand the abnormal development of gray and white matter in brain malformations. Knowledge gained from studying the abnormal laminar organization in brain malformations will serve as a reference for future studies of fetal brain malformations in-utero using MRI.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 3, 2013

Status Verified

May 1, 2008

Enrollment Period

2 years

First QC Date

May 23, 2008

Last Update Submit

December 2, 2013

Conditions

Keywords

Fetal DeathMagnetic Resonance ImagingAutopsyTelencephalonPyramidal Tracts

Study Arms (1)

1

Procedure: MR ImagingProcedure: Autopsy

Interventions

MR ImagingPROCEDURE

Postmortem MR will be included as part of the autopsy examination in cases of suspected brain malformations. Imaging will be done using 1.5T GE CV/I MRI magnet. The specimen is scanned, following fixation, using an 8-channel head coil or 8-channel knee coil, depending on the size of the brain. Structural postmortem MR will include spin-echo T1, axial SPGR, and T2 imaging in three planes. Diffusion tensor imaging will be performed in the coronal plane.

1
AutopsyPROCEDURE

Autopsy will be performed according to accepted standards, based on clinical indications. Macroscopic examination of the fetus will be performed initially , followed by organ removal for tissue fixation for a period of two weeks.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 fetal post mortem brains, with suspected diagnosis of brain malformation

You may qualify if:

  • suspected antenatal diagnosis of brain malformation who will undergo autopsy and MRI to further assess the malformations
  • above 18 weeks gestation

You may not qualify if:

  • significant autolysis of tissue specimens prior to tissue fixation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Macroscopic examination of the fetus will be performed initially follwed by organ removal for tissue fixation for a period of two weeks.

MeSH Terms

Conditions

Fetal Death

Interventions

Magnetic Resonance SpectroscopyAutopsy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Susan Blaser

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuro Radiologist

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 30, 2008

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

December 3, 2013

Record last verified: 2008-05

Locations