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Magnetic Resonance Imaging (MRI) of Ventriculomegaly: Morphology and Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870675
First Posted: March 27, 2009
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Boston Children’s Hospital
Information provided by (Responsible Party):
Deborah Levine, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  Purpose
This study compares the accuracy of fast magnetic resonance imaging (MRI) using the half Fourier single shot rapid acceleration with relaxation enhancement technique to ultrasound in the diagnosis of fetal abnormalities. The investigators' specific aim is to perform MRI examinations with ultrafast MRI on fetuses with sonographic morphologic abnormalities. The investigators' hypotheses are that 1) MRI will demonstrate fetal morphologic abnormalities; and 2) MRI will add additional information to the sonographic diagnosis which may directly affect maternal and/or neonatal care.

Condition
Ventriculomegaly

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI of Ventriculomegaly: Morphology and Outcome

Resource links provided by NLM:


Further study details as provided by Deborah Levine, National Institute for Biomedical Imaging and Bioengineering (NIBIB):

Primary Outcome Measures:
  • Live birth [ Time Frame: within 6 months of enrollment ]
  • Postnatal imaging abnormalities [ Time Frame: Within 3 years of birth ]
  • Postnatal developmental delay [ Time Frame: Within 3 years of birth ]

Enrollment: 434
Study Start Date: January 1996
Study Completion Date: June 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ventriculomegaly
Pregnant women carrying a fetus with the ultrasound finding of enlarged ventricles (ventriculomegaly).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women carrying a fetus diagnosed by ultrasound as having ventriculomegaly.
Criteria

Inclusion Criteria:

  • Sonographic finding of ventriculomegaly
  • Ability and willingness of the patient to provide informed consent and cooperate for the examination
  • Absence of contraindications for MRI (claustrophobia, pacemaker, intracranial clips, intra-articular ocular debris)
  • All patients must be greater than 18 years old and must be in the second or third trimester of pregnancy

Exclusion Criteria:

  • Contraindications to MRI
  • Age less than 18
  • First trimester of pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870675


Locations
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Beth Israel Deaconess Medical Center
Boston Children’s Hospital
Investigators
Principal Investigator: Deborah Levine, MD Beth Israel Deaconess Medical Center
  More Information

Publications:

Responsible Party: Deborah Levine, Professor of Radiology, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
ClinicalTrials.gov Identifier: NCT00870675     History of Changes
Other Study ID Numbers: 2001-P-00842/6
NIH NIBIB 01998
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Deborah Levine, National Institute for Biomedical Imaging and Bioengineering (NIBIB):
Ventriculomegaly
ultrasound
MRI
fetus

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases